Percutaneous heart pump

ABSTRACT

Disclosed herein are heart pumps that can include a catheter body and an impeller coupled with a distal end of the catheter body. The impeller can include a tip that is resealable or that includes a resealable member. The heart pump can also include a diffuser disposed between the distal end of the catheter body and the impeller, wherein the diffuser includes a flow directing surface.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/345,597, filed on Jan. 6, 2012, entitled Percutaneous Heart Pump,which claims priority to U.S. Provisional Application Ser. No.61/430,537 filed Jan. 6, 2011, entitled Percutaneous Heart Pump, thecontents of each of which are hereby incorporated by reference hereinfor all purposes.

BACKGROUND OF THE INVENTION Field of the Invention

This application is directed to heart pumps that can be appliedpercutaneously.

Description of the Related Art

Heart disease is a major health problem that claims many lives per year.After a heart attack, only a small number of patients can be treatedwith medicines or other non-invasive treatment. However, a significantnumber of patients can recover from a heart attack or cardiogenic shockif provided with mechanical circulatory support.

In a conventional approach, a blood pump having a fixed cross-section issurgically inserted a heart chamber, such as into the left ventricle ofthe heart and the aortic arch to assist the pumping function of theheart. Other known applications involve providing for pumping venousblood from the right ventricle to the pulmonary artery for support ofthe right side of the heart. The object of the surgically inserted pumpis to reduce the load on the heart muscle for a period of time, whichmay be as long as a week, allowing the affected heart muscle to recoverand heal. Surgical insertion, however, can cause additional seriousstresses in heart failure patients.

Percutaneous insertion of a left ventricular assist device (“LVAD”), aright ventricular assist device (“RVAD”) or in some cases a system forboth sides of the heart (sometimes called “biVAD”) therefore is desired.Conventional fixed cross-section ventricular assist devices designed toprovide near full heart flow rate are too large to be advancedpercutaneously, e.g., through the femoral artery. There is an urgentneed for a pumping device that can be inserted percutaneous and alsoprovide full cardiac rate flows of the left, right, or both the left andright sides of the heart when called for.

SUMMARY OF THE INVENTION

In one embodiment, a heart pump is provided that includes a catheterbody, a housing, an impeller, and a diffuser. The catheter body includesa proximal end, a distal end, and an elongate body extendingtherebetween. The housing is coupled with the distal end of the catheterbody and comprises a distal opening and a proximal opening. The impellerassembly is coupled with the distal end of the catheter body andpositioned within the housing. The diffuser can include a flow directingsurface. The diffuser is disposed between the distal end of the catheterbody and the impeller. The diffuser is configured to be positionedwithin the housing and adjacent the proximal opening.

In another embodiment, a heart pump is provided that includes a catheterbody comprising a proximal end, a distal end, and an elongate bodyextending therebetween. The pump also includes an impeller coupled withthe distal end of the catheter body and comprising an axial lumenpassing through a distal end of the impeller. The impeller comprises atip positioned at the distal end of the impeller, the tip comprising aresealable member having a resealable path.

In another embodiment, a heart pump is provided that comprises acatheter body, an impeller, and a sheath. The catheter body has aproximal end, a distal end, and an elongate structure extendingtherebetween. The impeller is coupled with the distal end of thecatheter body. The sheath is disposed over at least a portion of thedistal end of the catheter body. The sheath also has an expandabledistal end.

In another embodiment, a catheter assembly is provided that includes acatheter body, an impeller, and a deployment device. The catheter bodycomprises a proximal end, a distal end, and an elongate structureextending therebetween. The impeller is configured for relative motionin an axial direction, and is located at the distal end of the catheterbody. The deployment device is located at the proximal end of thecatheter assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the subject matter of the presentinventions and the various advantages thereof can be realized byreference to the following detailed description, in which reference ismade to the accompanying drawings in which:

FIG. 1 illustrates one embodiment of a heart pump configured forpercutaneous application and operation;

FIG. 1A is a plan view of one embodiment of a catheter assembly adaptedto be used with the heart pump of FIG. 1;

FIG. 2 is a detail view of a distal portion of the catheter assemblyillustrated in FIG. 1A;

FIG. 3 is an exploded view of a portion of an impeller assembly of thecatheter assembly of FIG. 1A;

FIG. 4A is a cross-sectional view of a distal portion of the catheterassembly, taken through the section plane 4A-4A shown in FIG. 2;

FIG. 4B is a detail view of the distal portion of the catheter assembly,taken at 4B-4B shown in FIG. 4A;

FIG. 5 is a cross-sectional perspective view of a bearing assembly ofthe catheter assembly of FIG. 1A;

FIG. 6 is a cross-sectional view of a bearing housing of the bearingassembly of FIG. 5;

FIG. 7 is a perspective view of one embodiment of a catheter body thatcan be used to house a drive shaft and to convey an infusant to thebearing housing of FIG. 5;

FIGS. 7A-7C show variations of the catheter body of FIG. 7;

FIG. 8 illustrates a surface configuration of one embodiment of abearing adapted to enhance or control flow of an infusant in the bearingassembly of FIG. 5;

FIG. 9 illustrates one embodiment of an impeller assembly;

FIGS. 9A, 9B-1, 9B-2, 10 and 10A illustrate details of furtherembodiments of impeller blades;

FIG. 11 is a cross-sectional view of a proximal portion of the catheterassembly, taken through the section plane 11-11 on FIG. 1A;

FIGS. 12, 12A, and 12B are cross-section views similar to that of FIG.11, illustrating an infusant outflow path;

FIGS. 13A-B are cross-sectional views of two embodiments of a blood pumpthat includes a diffuser;

FIGS. 14A-B are partial cross-sectional views illustrating oneembodiment of a blood pump including a retractable impeller assembly indeployed and retracted configurations, respectively;

FIGS. 15A-B illustrate a deployment device disposed at the proximal endof a catheter assembly illustrated in FIGS. 14A-B in deployed andretracted configurations, respectively;

FIG. 15C is a cross-sectional view of a structure for actuating thedeployment device illustrated in FIGS. 15A-B;

FIGS. 15D-F illustrate further embodiments of deployment devices thatcan actuate the catheter assembly between deployed and retractedconfigurations;

FIGS. 16A-C are cross-sectional views of three embodiments of aself-sealing impeller tip; and

FIGS. 17A-D are perspective views of variations of a sheath assemblyhaving an expandable distal portion.

A more detailed description of various embodiments of components forheart pumps useful to treat patients experiencing cardiac stress,including acute heart failure, are set forth below.

DETAILED DESCRIPTION

Major components of heart pumps that can be applied percutaneously to apatient are described below in Section I. Section II describes variousstructures that facilitate the rotatable support of a cantileveredimpeller. Section III describes various structures that facilitatedeployment and/or retrieval of one or more components of the distal end108 of the heart pump 10 within the cardiovascular system. Section IVdescribes various methods and techniques in connection with specificstructures of heart pumps

I. Overview of Heart Pumps

FIG. 1 illustrates one embodiment of a heart pump 10 that includes acatheter assembly 100 having a proximal end 104 adapted to connect to amotor 14 and a distal end 108 (see FIG. 1A) adapted to be insertedpercutaneously into a patient. The motor 14 is connected by a signalline 18 to a control module 22 that provides power and/or controlsignals to the motor 14. As discussed further below, the heart pump 10in various embodiments has an infusion system 26 and a patientmonitoring system 30.

The infusion system 26 can provide a number of benefits to the heartpump 10 which are discussed below. In one embodiment, the infusionsystem 26 includes a source of infusant 34, a fluid conduit 38 extendingfrom the infusant source 34 to the proximal end 104 of the catheterassembly 100 and a fluid conduit 42 extending from the proximal end ofthe catheter assembly 100 to a waste container 46. The flow of infusantto and from the catheter assembly 100 can be by any means, including agravity system or one or more pumps. In the illustrated embodiment, theinfusant source 34 includes an elevated container 50, which may besaline or another infusant as discussed below. Flow from the elevatedcontainer 50 can be regulated by a pressure cuff 54 to elevate thepressure of the fluid in the container 50 to increase flow or by a pinchvalve 58 or by other means.

The patient monitoring system 30 can be used to monitor the operation ofthe patient and/or the pump 10. For example, the patient monitoringsystem 30 can include a user interface 60 coupled with a source of data64. The data source 64 can include one or more patient conditionssensors, such as pressure sensors 68 that are in pressure communicationwith the patient and/or operating components within the patient. In oneembodiment, the pressure sensors 68 fluidly communicate by a conduit 72that extends between the sensors and a proximal portion of the catheterassembly 100. The conduit 72 can include a plurality of separablesegments and can include a valve 76 to enable or disable the pressurecommunication to the sensors 68.

The heart pump 10 is adapted to provide an acute or other short-termtreatment. A short-term treatment can be for less than a day or up toseveral days or weeks in some cases. With certain configurations thepump 10 can be used for a month or more.

The catheter assembly 100 extends between the proximal end 104 and thedistal end 108. An impeller assembly 116 disposed at the distal end 108is configured to pump blood to convey blood from one body cavity toanother. In one arrangement, the impeller assembly 116 conveys bloodproximally through or along a portion of the catheter assembly 100 toprovide assistance to the left ventricle of the heart. In anotherembodiment, the impeller assembly 116 conveys blood distally through oralong a portion of the catheter assembly 100 to provide assistance tothe right ventricle of the heart. The heart pump 10 is useful as a heartassist device for treating patients with acute heart failure or otherheart maladies. The heart pump 10 also can be used in connection with asurgical treatment to support the patient without providing fullcardiovascular bypass. A patient could be supported on the device forlonger term with proper controls and design.

The catheter assembly 100 is provided with a low profile configurationfor percutaneous insertion. For example, the distal end 108 of thecatheter assembly 100 can be configured to have about an 11 French(approximately 3.5 mm) size in a first configuration for insertion andan expanded configuration, such as up to about 21 French (approximately7 mm), once positioned in the body. The larger size facilitates greaterflow rates by the impeller assembly 116 as discussed below.

The catheter assembly 100 is configured to enable the distal end 108 toreach a heart chamber after being inserted initially into a peripheralvessel. For example, the catheter assembly 100 can have a suitablelength to reach the left ventricle and sufficient pushability andtorquability to traverse the intervening vasculature. The catheterassembly 100 may includes a multilumen catheter body 120 that isarranged to facilitate delivery and operation of the impeller assembly116. Further details concerning various embodiments of the catheter body120 are discussed below in connection with FIGS. 7-7C.

A drive system is provided to drive an impeller within the impellerassembly 116. The drive system includes a motor 14 and a suitablyconfigured drive controller (not shown) disposed within the controlmodule 22. The motor 14 is in various embodiments is configured to bedisposed outside the patient, e.g., adjacent to the proximal end 104 ofthe catheter assembly 100. In one advantageous embodiment, the drivesystem employs a magnetic drive arrangement. The motor 14 is arranged togenerate magnetic fields that will be sensed by permanent magnetsdisposed within the proximal end 104 of the catheter assembly 100. Thisarrangement facilitates very efficient generation of torque used todrive the impeller assembly 116, as discussed below.

Some embodiments described herein could be incorporated into a system inwhich a motor is miniaturized sufficiently to be inserted into thepatient in use, including into the vasculature. Such an embodiment couldbe operated by disposing control signal lines within the proximalportion of the catheter body 120. Also, it may be useful to provide thecapability to measure blood pressure at the distal end 108 using adevice disposed at the proximal end 104. For example, a pressure sensorat the distal end can communicate with a device outside the patientthrough a lumen of the catheter body 120. Various details of theseoptional features are described in U.S. Pat. No. 7,070,555, which isincorporated by reference herein for all purposes and in its entirety.

In another embodiment, a mechanical interface can be provided betweenthe motor and the proximal end 104 of the catheter assembly 100. Themechanical interface can be between the motor 14 and a drive shaftpositioned at the proximal end of the catheter assembly 100.

A torque coupling system is provided for transferring torque generatedby the drive system to the impeller assembly 116. The torque couplingsystem is discussed further in Section II(C)—Torque Coupling System (asdiscussed below), but in general can include magnetic interface betweenthe motor 14 and a drive assembly 146 disposed at the proximal end 104of the catheter assembly 100. The drive assembly 146 is coupled with aproximal end of an elongate drive shaft 148 in one embodiment. The driveshaft 148 extends between the drive assembly 146 and the impellerassembly 116. A distal portion of the drive shaft 148 is coupled withthe impeller assembly 116 as discussed below in connection with oneembodiment illustrated in FIGS. 4A and 4B. FIG. 11 shows one manner ofcoupling the proximal end of the drive shaft 148 with the drive assembly146.

As discussed above, the heart pump 10 may also includes an infusionsystem 26. FIG. 1A shows that the infusion system 26 can include aninfusion inflow assembly 150 provided adjacent to the proximal end 104in one embodiment. The infusion assembly 150 can be one component of aninfusion system that is configured to convey one or more fluids withinthe catheter assembly 100. The fluids can be conveyed distally withinthe catheter assembly 100, e.g., within the catheter body 120, tofacilitate operation of the impeller assembly 116, some aspect of atreatment, or both. In one embodiment, the infusion system is configuredto convey a lubricant, which can be saline, glucose, lactated Ringer'ssolution, acetated Ringer's solution, Hartmann's solution (e.g.,including compound sodium lactate), and D5W dextrose solution. Inanother embodiment, the infusion system is configured to convey amedication, or a substance that both acts as lubricant and medication.As sometimes used herein “infusant” is intended to be a broad term thatincludes any fluid or other matter that provides performance enhancementof a component of the heart pump 10 or therapeutic benefit, and can bewholly or partly extracted from the system during or after operation ofthe pump.

In one embodiment, the infusion inflow assembly 150 includes a catheterbody 154 having a luer or other suitable connector 158 disposed at aproximal end thereof and an inflow port in fluid communication with oneor more lumens within the catheter assembly 100. A lumen extendingthrough the catheter body 154 is adapted to be fluidly coupled with afluid source connected to the connector 158 to deliver the fluid intothe catheter assembly 100 and through one or more flow paths asdiscussed below in connection with FIGS. 4A, 4B, and 7-7C.

FIGS. 1A and 12 show that the catheter assembly 100 in variousembodiments also includes an outlet positioned at a location that isoutside the patient when the heart pump 10 is in use to allow infusantto be removed from the pump and from the patient during or after thetreatment. The outlet can be fluidly coupled with an infusant returnflow path in the catheter body 120 through a fluid port 144 disposed atthe proximal end 104.

The catheter assembly 100 can also include a sheath assembly 162configured to constrain the impeller assembly 116 in a low profileconfiguration in a first state and to permit the impeller assembly 116to expand to the enlarged configuration in a second state. The sheathassembly 162 has a proximal end 166, a distal end 170, and an elongatebody 174 extending therebetween. In one embodiment, the elongate body174 has a lumen extending between the proximal and distal ends 166, 170,the lumen being configured to be slidably disposed over the catheterbody 120. The arrangement permits the sheath assembly 162 to be actuatedbetween an advanced position and a retracted position. The retractedposition is one example of a second state enabling the impeller assembly116 to expand to an enlarged configuration. The advanced position is oneexample of a first state that enables the impeller assembly 116 to becollapsed to the low profile configuration. In some embodiments, a luer102 or other suitable connector is in fluid communication with theproximal end 166 of the sheath assembly 162. The luer 102 can beconfigured to deliver fluids to the catheter assembly 100, such aspriming fluid, infusant, or any other suitable fluid.

FIG. 1A illustrates a retracted position, in which the distal end 170 ofthe elongate body 174 is at a position proximal of the impeller assembly116. In an advanced position, the distal end 170 of the elongate body174 is positioned distal of at least a portion of the impeller assembly116. The sheath assembly 162 can be configured such that distaladvancement of the distal end 170 over the impeller assembly 116actuates the impeller assembly 116 from an enlarged state to a morecompact state (or low profile configuration), e.g., causing a changefrom the second state to the first state, as discussed above.

FIGS. 4A & 4B show the elongate body 174 as a single layer structurefrom the inner surface to the outer surface thereof. In anotherembodiment, the elongate body 174 has a multilayer construction. In onearrangement, the elongate body 174 has a first layer that is exposed tothe catheter body 120 and a second layer exposed that corresponds to anouter surface of the catheter assembly 100. A third layer can bedisposed between the first and second layers to reinforce the elongatebody 174, particularly adjacent to the distal end thereof to facilitatecollapse of the impeller assembly 116. In another construction, areinforcing structure can be embedded in an otherwise continuous tubularstructure forming the elongate body 174. For example, in someembodiments, the elongate body 174 can be reinforced with a metalliccoil.

FIG. 2 show that an impeller housing 202 is disposed at the distal end108. The impeller housing 202 can be considered part of the impellerassembly 116 in that it houses an impeller and provides clearancebetween the impeller and the anatomy to prevent any harmful interactionstherebetween. The housing 202 and the impeller are also carefullyintegrated to maintain an appropriate flow regime, e.g., from distal toproximal or from proximal to distal within the housing.

FIGS. 1A and 2 also show that the distal end 108 of the catheterassembly 100 includes an atraumatic tip 182 disposed distal of theimpeller assembly 116 in one embodiment. FIG. 1A shows that theatraumatic tip 182 can have an arcuate configuration such thatinteractions with the vasculature are minimally traumatic. The tip 182can also be configured as a positioning member. In particular, the tip182 can be rigid enough to help in positioning the impeller assembly 116relative to the anatomy. In one embodiment, the tip 182 is rigid enoughthat when it is urged against a heart structure such as the ventriclewall, a tactile feedback is provided to the clinician indicating thatthe impeller assembly 182 is properly positioned against the heartstructure.

II. Impeller Rotation and Support

The impeller assembly 116 can take any suitable form, but in variousembodiments includes an impeller 200 adapted to move a fluid such asblood from an inlet to an outlet of the catheter assembly 100. Incertain embodiments the impeller 200 can be cantilevered or otherwisesupported for rotation primarily at one end.

FIG. 3 shows that the impeller 200 includes a shaft 204, a central bodyor hub 208, and one or more blades 212.

The shaft 204 and hub 208 can be joined in any suitable fashion, such asby embedding a distal portion of the shaft within the hub 208. Theblades 212 can be spaced out proximal to distal along the axis of theshaft. In some embodiments, the blades 212 are provided in blade rows.FIG. 9 shows that the distal end of the shaft 204 can extend at least toan axial position corresponding to one of the blade rows. In someembodiments, the shaft 204 can be solid. In other embodiments, the shaft204 has a lumen extending axially through the hub so that a guidewirecan be passed through the catheter assembly 100. Details of variationswith a lumen are discussed further in U.S. application Ser. No.12/829,359, filed Jul. 1, 2010, titled Blood Pump With ExpandableCannula, which is hereby incorporated by reference herein in itsentirety and for all purposes.

A. Infusant Delivery and Removal System

The operation and duty cycle of the impeller assembly 116 can belengthened by providing a hydrodynamic bearing for supporting the shaft204. A hydrodynamic bearing can be supported by a lubricant, such asisotonic saline, which can be delivered in a continuous flow. Thelubricant can be delivered through the infusion system to an outsidesurface of the shaft 204. The infusant may be directed onto the shaftfrom a radially outward location. In some arrangements, the lubricantflow is controlled such that of a total lubricant volume introduced intothe proximal end of the cannula, a first portion of the total volume ofthe lubricant flows proximally along the shaft 204. In some embodiments,a second portion of the total volume flows distally along the shaft, thefirst volume being different from the second volume. The second portionof the total volume can be substantially equal to the total volumeintroduced into the proximal end of the cannula less the first volume.

FIGS. 3 to 8 show various structures for providing rotational support ofa proximal portion of the shaft 204 within the distal portion of thecatheter assembly 100. For example, as shown in FIG. 3, a bearingassembly 220 can be disposed at a distal end 224 of the multilumencatheter body 120. In one embodiment, the bearing assembly 224 includesa housing 228 (as shown in FIG. 4B) and one or more bearings configuredto support the proximal portion of the shaft 204. The bearing assembly224, as illustrated in more detail in FIG. 4B, includes a plurality ofbearings 232 a, 232 b disposed within the bearing housing 228. Variousmaterials that can be used for the bearings are discussed below.

FIG. 6 shows that the bearing housing 228 has a lumen 234 extendingtherethrough with a proximal enlarged portion 236 a and a distalenlarged portion 236 b. The housing 228 comprises a shoulder defining anarrow portion 240 of the lumen 234 disposed between the enlargedportions 236 a, 236 b. The first and second bearings 232 a, 232 b can bedisposed within the enlarged portions 236 a, 236 b of the bearinghousing 228.

In one arrangement, the proximal end of the shaft 204 (e.g., as shown inFIG. 4A) is received in and extends proximally of the second bearing 232b. In some embodiments there can be one bearing (e.g., only bearing 232a), while in other embodiments both bearings 232 a and 232 b can beused. In some embodiments, the bearing(s), e.g., bearings 232 a and/or232 b, can be friction fit or interference fit onto the impeller shaft204. Accordingly, the shaft 204 can be supported for rotation by thebearings 232 a, 232 b as well as in the narrow portion 240 of thehousing 228. In embodiments where the bearing(s) 232 a, 232 b arefriction or interference fit onto the shaft, the bearing(s) 232 a, 232 bcan be configured to rotate with the shaft 204 relative to the bearinghousing 228. Further, the bearing(s) 232 a, 232 b can have a relativelylarge clearance with the bearing housing 228. The clearance between theshaft 204 and the bearing housing 228, at regions that are not coupledwith the bearing, can be in the range of about 0.0005 to about 0.001inch. In certain embodiments, the clearance can be within a largerrange, such as at least about 0.0005 inches, about 0.001 inches or up toabout 0.005 inches. In embodiments with multiple bearing(s) 232 a, 232b, the clearance can be different for the bearings 232 a, 232 b, such asproviding a larger clearance at the proximal bearing 232 a.

In other embodiments, such as in FIG. 5, the bearing(s) 232 a, 232 b maynot be friction or interference fit onto the shaft 204. In theseembodiments, the bearing(s) 232 a, 232 b may be disposed within thebearing housing 228, for example by an interference or press fit. Theshaft 204 may then rotate with respect to the bearing(s) 232 a, 232 b,and there can be a clearance between the shaft 204 and the bearing(s)232 a, 232 b. The clearance between the shaft 204 and the bearings 232a, 232 b can be in the range of about 0.0005 to about 0.001 inch. Incertain embodiments, the clearance can be within a larger range, such asat least about 0.0005 inches, about 0.001 inches or up to about 0.005inches. The clearance can be different for the bearings 232 a, 232 b,such as providing a larger clearance at the proximal bearing 232 a. Incertain embodiments, the bearing housing 228 may provide a thrustsurface for bearing axial loads. In other embodiments, there may beother bearings located either distally or proximally of the bearinghousing 228 that are configured to bear axial loads. In otherembodiments, the fit between the bearings 232 a, 232 b and the shaft 204can be tight, which can also assist in bearing axial loads in someaspects.

At least the proximal portion of the shaft 204 can be made of a materialthat will not corrode or otherwise be made to be inert when immersed inthe lubricant or other infusant. The material may be one that will notcorrode in isotonic saline. Suitable materials may include a widevariety of metals, including alloys, and at least saline-resistantstainless steel and nickel-based alloys. Also, the shaft 204 could bemade as a composite to include advantageous properties of a plurality ofmaterials. In some cases the shaft 204 could be formed as a polymer. Theclass of polymers selected would include those that can form a shaft 204of a certain stiffness suitable in this application. For example,polycarbonate or PEEK could be used. In certain configurations, thepolycarbonate, PEEK, or other suitable polymer can provide enhancedperformance by being combined with a second material or structure. Aglass or carbon filled polycarbonate or other stiff polymer could alsobe used.

As discussed above, a hydrodynamic bearing between the shaft 204 and thebearings 232 a, 232 b may be utilized in various embodiments. In onesuch arrangement, a continuously replenished fluid film is provided atleast between the inner wall of the bearing housing and an adjacentmoving structure, such as the impeller shaft or an outer surface of abearing. For example, the bearing housing 228 can be configured topermit a lubricant to be delivered therethrough into the lumen 234. Thebearing housing 232 can include a plurality of channels 260 disposedtherein extending proximally from a plurality of ports 264 located atthe narrow portion 240 of the housing 228. Each port 264 can communicatewith one of the channels 260 to provide fluid communication into thelumen 234.

As shown in FIG. 5, the channels 260 can be formed in the wall of thehousing 228. In one embodiment, the channels 260 are formed as opendepressions, e.g., as flutes, extending along the housing 228. In thisembodiment, the channels 260 can be enclosed by a separate structure,such as a separate outer sleeve, that is disposed around the housing228. FIG. 4B shows that a proximal portion 268 of the impeller housing202 can be sized to tightly fit over the outer surface of the bearinghousing 228, enclosing the radially outward portion of the channels 260.In this arrangement, at least a portion of a flow path is formed betweenan outer surface of the bearing housing 232 and a separate outer sleeve.

Fluid communication between the port 264 in the bearing housing 228 andthe infusion inflow assembly 150 can be by any suitable combination oflumens within the catheter assembly 100. For example, in one embodiment,each of the channels 260 has a proximal port 272 that communicationswith an annular space 274 formed in the catheter assembly 100. Theannular space 274 can be formed between a plurality of separate overlaidstructures in the catheter assembly 100. FIGS. 4A and 4B show that theannular space 274 is formed between an outer surface 278 of themultilumen catheter body 120 and an inner surface of the proximal length268 of the housing 202.

Fluid communication is provided in the catheter assembly 100 between thespace 274 and the infusion inflow assembly 150. For example, a pluralityof lumens 282 formed in the multi-lumen catheter body 120 can bedispersed circumferentially about the catheter body 120 at a peripheralcircumferential region 284, as illustrated in FIGS. 7-7C. The peripheralposition of the lumens 282 enables a central area of the catheter body120 to be dedicated to a central lumen 286. By providing a plurality ofsmaller lumens 282 located at the periphery, a relatively large flowrate can be delivered through a relatively small circumferential band(when considered in cross-section) of the catheter body 120. Each of thelumen 282 has a distal port 290 that communicates with the space 274.

A proximal portion of the lumens 282 can take any suitable form. Forexample, the lumens 282 can communicate at their proximal end with aflow diverting structure (not shown) that is in fluid communication withthe infusion inflow assembly 150. As described herein, in someembodiments the lumen 282 can be disposed circumferentially about thecentral lumen 286. The catheter assembly 100 can include a flowdiverting structure or connector, e.g., disposed about the proximal endof the catheter body 120 that is configured to divert the infusant intothe lumens 282 for distally directed flow therein. In other embodiments,the catheter assembly 120 can include a flow diverting structuredisposed adjacent the distal end thereof that is configured to divertthe infusant into the lumens 282 from the central lumen 286 forproximally directed flow in the lumens 282.

FIG. 5 includes arrows that illustrate the flow of infusant into thebearing assembly 220. In one arrangement, the inflow of infusant isindicated by an arrow 300 which is shown pointing distally within one ofthe channels 260 of the bearing housing 228. The infusant flow entersthe bearing housing through the ports 264. Although flow is shown in onechannel 260, corresponding flow may be provided in each of a pluralityof channels 260 disposed around the central lumen 234. An arrow 304illustrates that at least a portion of the infusant delivered throughthe port 264 may flow generally proximally within the bearing housing228. An arrow 308 illustrates that at least a portion of the infusantdelivered through the port 264 may flow generally distally within thebearing housing 228.

FIG. 5 illustrates the arrows 304, 308 as proximally and distallydirected, respectively. However, the high speed rotation of the impellershaft 204 within the housing 228 will create a thin film of lubricantspacing the impeller shaft 204 from the surfaces of the bearings 232 a,232 b. This thin film will extend all the way around the shaft 204 andthus each portion of the flow will have a spiral or helical flowdirection.

The bearings 232 a, 232 b can have different configurations to enhancethe performance of the pump 10. For example, the proximal bearing 232 acan be longer along the longitudinal axis of the bearing housing 228than the distal bearing 232 b. A longer proximal bearing 232 a isbelieved to better control runout of the shaft 204. Better runoutcontrol on the shaft 204 is believed to enhance the control of theposition of the blades 212 relative to the housing 202. Less runoutreduces excessive variation in the gap between the blades 212 and thehousing 202, providing biocompatibility benefits such as reducedhemolysis.

In some embodiments, such as those in FIG. 5 where the bearings 232 a,232 b are not friction fit or interference fit onto the shaft 204, thedistal bearing 232 b has a smaller inner diameter than the proximalbearing 232 a. If the shaft 204 has a constant diameter, the smallerinner diameter should provide greater control of angular deflection ofthe shaft. Controlling angular deflection can enhance relative positioncontrol of the blades 212 and housing 202, providing blood handlingbenefits such as reduced hemolysis. A smaller clearance could also beprovided by enlarging the diameter of the shaft 204 at the axialposition of the distal bearing. In some embodiments, the larger innerdiameter of the bearing 232 b enables a larger volume of lubricant toflow proximally and a lesser volume to flow distally in the lumen 234.

The continuous introduction of lubricant maintains a constant,predictable and durable rotational bearing state between stationarycomponent, e.g., the bearing housing 282, and a moving component, e.g.,the shaft 204, a component of the bearings 232 a, 232 b, or both theshaft 204 and a component of the bearings 232 a, 232 b. Also, continuouslubricant inflow provides a means for removing heat generated by therelative motion between the shaft 204 and the bearings. Also, theinfusant can create fluid pressure within the catheter assembly 100 thatcan push debris generated within or by the pump 10 out of the bearinghousing 220. Enhancing the volume of infusant that flows along the pathindicated by the arrow 304 enhances the likelihood that debris generatedby or present in the pump will be removed from the proximal end ratherthan to be trapped inside the distal portion of the catheter assembly100.

Another technique for controlling infusant flow in the lumen 234 is tolocate the port 264 between the bearings 232 a, 232 b and closer to oneof the bearing. For example, the ports 264 can be located adjacent tothe proximal bearing 232 a in one embodiment. This provides a shorterpath of egress out of the narrow portion 240 of the bearing housing 228in the proximal direction.

Other strategies for controlling the flow of infusant within the bearinghousing 228 include modifying a surface within one or more of thebearings 232 a, 232 b. FIG. 8 shows a surface modification 233 providedin a bearing 232 a to enhance proximally directed flow. The surfacemodification 233 comprises a plurality of axially oriented grooves 235in one embodiment. In another embodiment, the surface modification 233includes one or more spiral grooves. The spiral grooves can be formedwith a groove entrance that is substantially parallel with a flowdirection of infusant between the bearings 232 a, 232 b such that areduction of velocity of the flow is minimized. In one embodiment, eachspiral groove includes at least about 3 turns disposed on the innersurface of the bearing between the proximal and distal ends of thebearing. In another embodiment, each spiral groove has adjacent turnsthat are spaced apart by a minimum pitch of 0.125 inches (3.2 mm). Inanother embodiment, each spiral groove has an axial density of about 32turns per inch (about 1.3 turns per mm). The grooves are formed in thesurface 237 of the bearing 232 a upon which the impeller shaft 204 issupported. The grooves 235 locally enlarge the clearance between theshaft 204 and the surface 237 so that a greater volume of infusant canflow distal-to-proximal across the bearing 232 a. The surfacemodification 233 reduces back-pressure limiting the distal-to-proximalflow across the bearing 232 a.

In other embodiments, it may be desirable to enhance distally directedflow. For example, the infusant may be provided with a fluid intended tobe delivered to the patient. In such embodiments, the surfacemodification 233 can be provided on the distal bearing 232 b. In certainembodiments, both proximal and distal bearings 232 a, 232 b are providedwith flow enhancing modifications to enhance heat transfer or purging ofthe bearing assembly 220. In such embodiments, one of the bearings mayhave a greater degree of flow enhancement provided on the bearingsurface.

The arrangement of the bearing assembly 220 can be a factor in selectingan appropriate infusant. Saline is a preferred infusant, but othersufficiently biocompatible infusants could be used. Other embodimentsare configured such that little or no infusant flows out of the pumpinto the patient. For such embodiments, other infusant fluids can beused, such as glucose.

FIG. 7 illustrates further features of the catheter body 120. Thecatheter body 120 comprises an inner most portion 320 that defines thecentral lumen 286. The inner most portion 320 is disposed within, e.g.,circumferentially surrounded by, the peripheral circumferential region284. A continuous outer circumferential region 324 can be providedaround the peripheral circumferential region 284 to fully enclose thelumens 282, discussed above. FIGS. 4A and 4B illustrate that a distalend of the inner most portion 320 is configured to be received andsecured within a proximal portion of the lumen 234 within the bearinghousing 228. FIG. 4B illustrates that a region of overlap can beprovided between a distal portion of the inner most portion 320 and aproximal portion of the bearing housing 228. This construction providesa continuous lumen defined in part by the central lumen 286 of thecatheter body 120 and in part by the lumen 234 of the bearing housing.In another arrangement, the bearing housing 228 and the catheter body120 are joined by a coupler that enhances the sealing between infusantinflow through the lumens 282 and the channels 260 and the infusantoutflow through the central lumen 286. As discussed further below, thiscontinuous lumen provides a space for the rotation of the shaft 204 ofthe impeller assembly 116 and the drive shaft 148 of the torque couplingsystem.

The physical connection between the bearing housing 228 and the catheterbody 120 can be achieved in any suitable manner. FIG. 3 illustrates thatin one arrangement, a slideable connection is provided. In thisarrangement, a rod 332 is provided between the bearing housing 228 andthe catheter body 120. The rod 332 can have any suitable configuration,but may have a proximal end configured to be received in a recess orlumen formed in the catheter body 120 and a distal end 340 configured tocouple with the bearing housing 228. FIG. 3 shows that the distal end340 of the rod 332 can be configured to engage with a feature of thebearing housing 228 so that a limited range of sliding is permitted.

In one embodiment, the bearing housing 228 has an elongate channel 342configured to receive a middle portion of the rod 332 and an enlargeddepression 344 located at the distal end of the channel 342. Thedepression 344 has a width W that is sufficient to receive a wide distalend of the rod 332. The depression 344 can be configured to have anaxial length along the housing 228 that can define a range of motion ofthe bearing housing 228 relative to the catheter body 120.

In one arrangement, the bearing housing 228 is positioned relative tothe catheter body 120 and the rod 332 such that the distal portion ofthe rod 332 is located at the distal end of the depression 344.Thereafter, the catheter assembly 100 can be manipulated such that thebearing housing 228 moves distally relative to the catheter body 120 andthe rod 332 such that the distal portion of the rod 332 is located atthe proximal end of the depression 344. In the distal position, theimpeller assembly 116 is located more distally than in the proximalposition. As discussed further below, this enables a variety oftechniques for unfurling the impeller blades 212 within the housing 202.

B. Bearing Configurations

Any suitable bearing can be used in the catheter assembly 100. Theprovision of an infusant for hydrodynamic support enables a wide rangeof bearing materials to be used. If saline or other more corrosiveinfusant is used, the bearing must be carefully configured to notdegrade within the expected duty cycle of the pump 10. Some polymericmaterials are advantageously not degraded by isotonic saline, and areacceptable materials from this perspective. Under the fluid-dynamicconditions, a hydrodynamic bearing that is supported by a biocompatibleinfusant such as isotonic saline is preferred. It is believed thatcertain polymer bearings in combination with isotonic saline can supportsuch conditions as 35,000-50,000 psi-ft/min for an appropriate dutycycle. Other aspects that can guide the choice of bearing configurationsinclude minimizing thermal expansion, given the heat that could begenerated in the heart pump 10, and minimizing moisture absorption.

Any suitable polymeric material may be used for the bearings 232 a, 232b. The polymeric material can include a homopolymer, a copolymer, or amixture of polymers. The polymeric material can include thermoplastic orthermoset polymers. Examples of polymers that can be used for bearings232 a, 232 b include, but are not limited to, one or more of apolyketone, a polyether, a polyacetal, a polyamide-imide, a polyacetal,polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE), andpolyphenylene sulfide (PPS).

The polymeric material can also include (e.g., can be mixed, combined,and/or filled with) one or more additives such as a reinforcer and alubricant. Specific additives include, but are not limited to, graphite,carbon fiber, glass fiber, and PTFE. Those of ordinary skill in the artmay appreciate that the additives may be polymeric or non-polymeric. Insome embodiments, the polymeric material used for bearings 232 a and/or232 b can include PEEK, carbon fiber, PTFE, and graphite. In otherembodiments, the polymeric material can include PPS and glass fiber. Inyet other embodiments, the polymeric material can include apolyamide-imide polymer, carbon fiber, and graphite. The polymericmaterial can include any suitable amount of additive(s). For example,the polymeric material can include a total amount of additive(s) in therange of from about 1 wt % to about 50 wt %, based on the total weightof the polymeric material. In other embodiments, the polymeric materialused for bearings 232 a, 232 b may not include any additives.

The polymeric material chosen for bearings 232 a, 232 b can haveparticular characteristics that advantageously affect the performance ofthe bearings. For example, in order to minimize thermal expansion causedby the heat generated in the heart pump 10, a preferred material wouldbe subject to a minimum of dimensional change, and can have acoefficient of thermal expansion in the range of from about 1.2×10⁻⁵°F.⁻¹ to about 25.2×10⁻⁵° F.⁻¹. In other embodiments, the polymer usedfor bearings 232 a, 232 b has a coefficient of friction in the range offrom about 0.15 to about 0.3. In another example, in order to minimizeor prevent water absorption, the selected polymeric material can have awater adsorption in the range of from about 0.01% to about 0.4% over a24 hour period. In yet another example, the polymeric material can besuitable for high pressure and velocity performance, and can have alimiting pressure-velocity (PV) in the range of from about 20,000psi-ft/min to about 50,000 psi-ft/min.

The polymeric material used for bearings 232 a, 232 b may becommercially available. Examples of suitable, commercially-availablepolymeric materials include, but are not limited to, Ketron PEEK-HPV,Turcite A, Turcite X, Turcite TX, Rulon LR, Rulon J, Rulon 641, RulonAR, Techtron HPV PPS, Ryton PPS, Torlon 4301, and Torlon 4501. In someembodiments, the polymeric material used for bearings 232 a, 232 b isKetron PEEK-HPV.

Of course, other bearing configurations and/or materials would besuitable under other conditions, e.g., with less corrosive infusants orif a hydrostatic or non-hydraulic bearing is used.

C. Torque Coupling Systems

A torque coupling system is provided to rotate the impeller 200 at ahigh rate to move blood from inside a heart camber to a location withina patient's vasculature in amounts sufficient to sustain the patient orprovide treatment to the patient. The torque coupling system couples theimpeller 200 with the motor 136, which may be disposed outside thepatient. It is expected that the impeller 200 and the drive shaft 148are to be rotated at 25,000-30,000 revolutions per minute for a periodof seven to ten days. To provide reliable performance under theseconditions, isotonic saline or other lubricant is provided between thedrive shaft 148 and stationary components therearound.

FIGS. 11 and 4B illustrate proximal and distal portions 400, 404 of thedrive shaft 148. The proximal portion 400 is coupled with the driveassembly 146 such that rotation of the drive assembly 146 rotates thedrive shaft 148. The distal portion 404 of drive shaft 148 is coupledwith the impeller shaft 204 such that rotation of the drive shaft 148causes rotation of the impeller shaft 204. The drive shaft 148 alsoincludes an elongate body 408 that extends between the proximal anddistal portions 400, 404. The elongate portion 408 comprises a lumen 412extending therethrough.

The size of the elongate body 408 may be as small as possible tominimize the cross-sectional profile of the catheter assembly 100. Thecross-sectional profile of the catheter assembly 100 corresponds to thecrossing profile of the catheter assembly, which limits where the systemcan be inserted into the vasculature. The lumen 412 is sized to permit aguidewire to be advanced therethrough in some embodiments. The use of aguidewire is optional, but may simplify insertion.

In one embodiment, the elongate body 408 comprises a multi-layerconstruction. In some embodiments, each layer can include at least onecoil wire or a plurality of coil wires all wound in a same orientation.For example, a two-layer, counter-wound wire construction isparticularly advantageous. A first layer (e.g., an inner layer) of theelongate body 408 is provided by a coiled wire ofnickel-molybdenum-chromium alloy, such as 35NLT or MP35N. In otherembodiments, the wire material can be MP35N LT. In one embodiment, thewire has a 0.008 inch diameter and the coil has a 5 filar right-handwound construction. The outer diameter of the first layer may be about0.071 inch. A second layer (e.g., an outer layer) of the elongate body408 can include the same material as the first layer, disposed on theoutside of the first layer. The first and second layers can be wound inthe same direction, or in opposite directions. For example, in someembodiments the first layer (e.g., an inner layer) can be left-handwound and the second layer (e.g., an outer layer) can be right-handwound, or vice versa. In other embodiments, both the first and secondlayers can be left-hand wound. In yet other embodiments, both the firstand second layers can be right-hand wound. The wound coil wireconstruction can advantageously facilitate proximal and/or distal flowof infusant along the outer layer of the elongate body 408. For example,the outer layer can be constructed such that the infusant travels alongthe coil and/or in the direction of the winding. Those skilled in theart may appreciate that, depending on the direction of rotation of theelongate body 408, the infusant flow can advantageously be directedeither proximally or distally. The second layer may be a 5 filarleft-hand wound construction. In one embodiment, each layer is formedusing a 0.008 inch diameter wire, in the above-noted coiledconfiguration. In other embodiments, the elongate body 408 can includethree or more coil wire layers, wherein the layers are wound inalternating directions. In some embodiments, the outer diameter of thesecond layer can be between about 0.072 inch and about 0.074 inch, whilein other embodiments the diameter can be much larger or smaller. In someaspects, for example, the outer diameter of the second layer can beabout 0.073 inch. The inner diameter of the elongate body 408 can be atleast about 0.039 inch in some implementations. In some embodiments, oneor more ends of the elongate body 408 can be welded and square cut, forexample, with a 0.1 inch maximum weld length on each end. The length ofthe elongate body 408 can vary, but in some embodiments, the length canbe between about 47 inches and 48 inches, for example, about 47.5inches.

Other materials and other constructions are possible. The elongate body408 can be made of other non-ferrous metals or other corrosion resistantmaterial or constructions with appropriate modulus. Other materials thatcould meet the corrosion requirements include stainless steel (e.g.,302, 304, or 316). In certain embodiments, the elongate body 408 canhave a structure that enables other materials to be used. For examplevarying at least one of coil layers, filars, wire diameter, and coildiameter may enable an otherwise less robust material to operate belowthe fatigue stress of that material.

In another embodiment, a four layer construction is provided. The fourlayers comprise three wire-wound layers, e.g., similar to thearrangement described above, but included a third wound layer on theouter surface of the second layer. A low friction layer can be disposedon the outside surface of the elongate body 408. One material that couldbe used as a low-friction layer is PTFE, known commercially as Teflon®.The low-friction layer should be configured to have sufficient wearresistance, such as by selection of the appropriate PTFE material, e.g.polyphenylene sulphone-filled PTFE, and/or by insuring appropriateinfusant flow is maintained during the entire duration of use of thedevice in order to prevent undesirable local elevated temperature of thePTFE material.

The drive shaft 148 operates within the multilumen catheter body 120.Because the drive shaft 148 is rotated at a very high rate when in usewithin the multilumen catheter body 120, the configuration of thesurface forming the central lumen 286 is important. In some embodiments,this inner surface has high lubricity and high wear resistance. Onematerial that can be used for the inner surface of the catheter body 120is high density polyethylene (HDPE), which provides sufficient lubricityand wear resistance. In one embodiment, the entire multilumen catheterbody 120 is formed of HDPE. PTFE provides good lubricity and could beused if made sufficiently wear resistant. One way to increase the wearresistance of PTFE is to impregnate it with polyphenylene sulphone(PPSO₂), another is to gamma irradiate the material. One way to increasethe lubricity of Polyimide materials is to impregnate it with Graphite,another is to impregnate it with Graphite and PTFE.

FIG. 4B shows a clearance 412 between the elongate body 408 of the driveshaft 148 and the inner surface of the multilumen catheter body 120. Theclearance 412 may be about 0.005 inch. Along a diameter between oppositesides of the inner surface of the central lumen 286 and outer surface ofthe elongate body 408 includes about 0.010 inch of space or diametricclearance. A larger minimum clearance may be desirable if the crossingprofile can be enlarged or if other structures of the catheter assembly100 can be made thinner or eliminated to allow more room between theelongate body 408 and the central lumen 286.

FIGS. 11 and 12 show further details of the drive assembly 146, which isdisposed at the proximal end 104 of the catheter assembly 100. The driveassembly 146 includes a drive housing 450 having a recess or cavity 454disposed therein. The cavity 454 is configured for mounting a rotorsupport shaft 458 for rotation therein. The support shaft 458 has aproximal end and a distal end and a plurality of components mountedthereon. The distal end of the support shaft 458 has a recess 462 formedtherein to receive a proximal end of the drive shaft 148. The supportshaft 458 may also have a lumen 466 disposed therein for slideablyreceiving a guidewire.

A rotor 470 is mounted on an outer surface of the support shaft 458between sleeve bearings 474 a, 474 b, as shown in FIG. 12. The rotor 470can take any suitable form, but in one embodiment includes an elongatemagnet 476 disposed between proximal and distal flywheels 478 a, 478 b.

The proximal end of the support shaft 458 has a tapered port 480 forreceiving the guidewire. The proximal end can be configured for engagingthe motor 136 in some embodiments. In other embodiments, a magneticfield is induced by the motor 136 in a manner that creates torque androtation of the shaft 458.

An infusant outflow path 482 is provided within the drive assembly 146.The outflow path 482 is provided between an outer surface of the supportshaft 458 and an inner surface 486 of the distal bearing. The flow path482 continues from the distal bearing 474 b radially outwardly alongthrust surfaces 490 a. The flow path continues proximally between theouter surface of the rotor 470 and the inner surface defining the cavity454. The flow path 482 continues radially inwardly along the thrustsurface 490 a toward the support shaft 458. The flow path 482 continuesproximally between the support shaft 458 and the proximal bearing 474 a.Proximal of the bearing 474 a, the flow of infusant exits the catheterassembly 100 through an outflow port 144 through which it can bedirected to the waste container 46 or discarded. The flow path is shownin more detail in FIGS. 1, 12, 12A, and 12B.

III. Structures that Facilitate Deployment and Retreival

The catheter assembly 100 can include one or more features thatfacilitate the deployment and/or retrieval of one or more components ofthe distal end 108 of the heart catheter assembly 100 (e.g., theimpeller assembly 116 or a portion thereof).

A. Optionally-Expandable Diffuser

As shown in FIGS. 13A and 13B, the pump can include a diffuser 502 a,502 b. As illustrated in FIG. 13A, in some embodiments the diffuser 502a is connected to the impeller hub 208. For example, the diffuser 502 acan be integral, or form a unitary structure, with the impeller hub 208.In another example, the proximal end of the impeller hub 208 can includethe diffuser 502 a. As illustrated in FIG. 13B, in other embodiments,the diffuser 502 b is separate from (e.g., not connected to) theimpeller hub 208.

The diffuser 502 a, 502 b can be disposed between the distal end of theelongate body of the catheter body and the impeller. The diffuser 502 a,502 b can be configured to be positioned within the housing 202 andadjacent to the proximal opening of the housing. In some embodiments,the diffuser 502 a, 502 b can be axially aligned with the proximalopening of the housing 202. Advantageously, this configuration canmaximize the flow directing capabilities of the diffuser 502 a, 502 b,as discussed further herein. The diffuser 502 a, 502 b can be locatedadjacent the proximal end of the hub 208. The diffuser 502 a, 502 b caninclude a proximal end 504 a, 504 b and a distal end 505 a, 505 b. Theproximal end 504 a, 504 b of the diffuser 502 a, 502 b can be positionedadjacent the distal end of the bearing housing 228 (e.g., over a bearing516 and/or a front thrust washer 518). As shown in FIG. 13A, theproximal end 504 a can be separated from the bearing 516 by a gap 522.The gap 522 can have an axial length generally equal to the length ofthe bearing 516. The gap 522 can also be generally cylindrical with alongitudinal axis that is aligned with the longitudinal axis of theimpeller shaft 204. The distal end 505 a, 505 b can be located adjacentthe proximal end of the impeller hub 208. The diffuser 502 a, 502 b caninclude a flow directing surface. For example, an outer surface 513 ofthe diffuser 502 a, 502 b can form a curved line from the proximal end504 a, 504 b to the distal end 505 a, 505 b, as illustrated in FIGS.13A-B. As viewed from the proximal or distal end, the diffuser 502 a,502 b can have a generally circular cross sectional shape. As shown inFIGS. 13A and 13B, the diameter of the diffuser 502 a, 502 b can begreatest in the mid section and can taper to a smaller diameter in thedistal and/or proximal directions. The diffuser 502 a, 502 b can have amaximum diameter that is generally greater than the diameter of the hub208 and/or the bearing housing 228. The diameter of the proximal end 504a, 504 b can be generally equal to the diameter of the bearing housing228. The diameter of the distal end 505 a, 505 b can be generally equalto the diameter of the hub 208. The diffuser 502 a, 502 b may bereferred to herein as a bulge, and in various embodiments can have aradially enlarged portion disposed downstream of the impeller.

Advantageously, the relatively large diameter and/or the curved outersurface can assist in directing (e.g., diffusing) fluid flow out of thehousing 202. The geometry of the diffuser 502 a, 502 b (e.g., the radiusof curvature of the outer surface) can be optimized to control desiredfluid properties such as boundary layer flow, laminar flow, and pressuregradients and to reduce outlet flow losses.

The diffuser 502 a, 502 b can include a wall 511. The wall 511 caninclude an inner surface 512 and the outer surface 513, described above.The wall 511 can have a thickness extending from the inner surface 512to the outer surface 513. In some embodiments, the wall 511 can have agenerally uniform thickness along the axial length of the diffuser 502a, 502 b. One advantage of a generally uniform wall thickness is thatthe diffuser 502 b can be more easily expanded and/or collapsed, asdescribed herein. In other embodiments, the wall 511 can have a variablethickness along the axial length of the diffuser 502 a, 502 b. Forexample, as illustrated in FIG. 13A, the thickness of the wall 511 canincrease in the distal direction. One advantage of a variable thicknesswall is that it can have variable structural strength. For example, awall having a thickness that increases distally can advantageously havegreater strength in areas that are most exposed to oncoming blood flow.

The inner surface 512 can define a chamber 506 through which theimpeller shaft 204 can pass. As shown in FIG. 13A, the diffuser 502 acan form part of the proximal end of the hub 208 of the impeller 200(e.g., the hub 208 can be connected to the diffuser 502 a). Thus, thediffuser 502 a can rotate with the rotating hub 208. The diffuser 502 acan also include a proximal cavity outlet 508. As shown in FIG. 13B, thediffuser 502 b can be a component separate from the impeller 200. Inthis embodiment, the diffuser 502 b can be stationary when the hub 208is rotating. The diffuser 502 b can also include a distal cavity outlet510.

There can be many advantages to including a diffuser 502 a that isconnected to the impeller hub 208. For example, the unitary constructioncan be easier to manufacture and/or assemble. As described herein, thedistal end of the diffuser 502 a can be relatively thick and strong(e.g., stiff). In addition, it can be advantageous for the infusant toexit the catheter assembly 100 at the proximal outlet 508, which isgenerally at the downstream end of the diffuser 502 a.

There can also be advantages to including a diffuser 502 b that is astructure separate from and not directly attached to the impeller hub208. In some embodiments, the diffuser 502 b can be made from a materialthat is different from the material used to make impeller hub 208. Forexample, the diffuser 502 b can be made from a material that isrelatively more flexible (softer) than the material of the impeller hub208. In other embodiments, the wall 511 of diffuser 502 b can have agenerally uniform thickness. These features of diffuser 502 b canfacilitate the expansion and/or contraction of the diffuser 502 b,described further herein.

As shown in FIGS. 13A and 13B, the diffuser 502 a, 502 b can begenerally hollow, as defined by the chamber 506. The diffuser 502 a, 502b can be sufficiently hollow and can be made of a relatively flexiblematerial (e.g., a polymer or elastomer) to be expandable and/orcollapsible. For example, the maximum diameter of the diffuser 502 a,502 b can expand from a first diameter to a second diameter.Advantageously, the collapsible diffuser 502 a, 502 b can have adeployed, expanded configuration, and a retracted, collapsedconfiguration. In the deployed, expanded configuration, the diffuser 502a, 502 b can have a maximum diameter (e.g., as measured at themid-section or bulge) that is generally greater than the diameter of thehub 208 and/or the bearing housing 228. In the retracted, collapsedconfiguration, the diffuser 502 a, 502 b can have a reduced diameter.For example, in the retracted, collapsed configuration, the diffuser 502a, 502 b can have a maximum diameter that is generally less than orequal to the diameter of the hub 208 and/or the bearing housing 228.Although described as having a diameter, those skilled in the art mayappreciate that while retracted and/or collapsed, the diffuser 502 a,502 b may not have a generally circular cross section. A collapsiblediffuser can be advantageous compared to a non-collapsible diffuserbecause a collapsible diffuser can allow the overall structure tomaintain and low profile for the purpose of retracting back into asheath and for insertion into and/or removal from a patient.

In some embodiments, the relatively flexible material itself may not besignificantly expandable (e.g., stretchable and/or elastic). Rather, theterms “expandable” and “collapsible” can refer to the overall expansionand/or collapse of the chamber 506 of the diffuser 502 a, 502 b. Inother embodiments, the relatively flexible material itself may besignificantly expandable (e.g., balloon-like).

The chamber 506 can be configured (e.g., sized) to allow fluid (e.g.,infusant) flow through the diffuser 502 a, 502 b. The diffuser 502 a,502 b can be configured for fluid communication with a fluid, such as aninfusant, that passes through the bearing assembly 220. The bearingassembly 220 illustrated in FIGS. 13A and 13B can have many, if not all,of the same features as described with respect to the bearing assembly220 illustrated in FIG. 5. As shown in FIGS. 13A and 13B, the infusantcan follow an infusant path 514 a, 514 b out of the bearing assembly 220and into the diffuser 502 a, 502 b via a passage or cavity 520 betweenthe bearing 516 and the washer 518. For at least a portion of theinfusant path 514 a, 514 b, the infusant can travel distally. In someembodiments, at least a portion of the infusant path 514 a, 514 b can benon-helical (e.g., generally linear). In other embodiments, at least aportion of the infusant path 514 a, 514 b can be generally helical. Thehelical shape of the infusant path 514 a, 514 b can be caused at leastin part by rotation of one or more components of the impeller assembly116 (e.g., the impeller shaft 204 and/or impeller hub 208).

As illustrated in FIG. 13A, the infusant path 514 a can extend from theproximal end 504 a to the distal end 505 a and can return back to theproximal end 504 a to exit the proximal outlet 508 via the gap 522. Theportion of the infusant path 514 a that extends from the proximal end504 a to the distal end 505 a is helical (e.g., can encircle theimpeller shaft 204 one or more times along the axial length of thepath). The return portion of the infusant path 514 a can be non-helical(e.g., generally linear). The return portion of the infusant path 514 acan be non-helical at least in part because the return portion canfollow the curved interior surface 512 of the diffuser wall 511. In use,the infusant can exit the bearing assembly 220 at the cavity 520 toenter the chamber 506. At least a portion of the infusant can thenfollow infusant path 514 a to travel helically around the impeller shaft204 in the distal direction until the distal end 505 a is reached. Theinfusant then changes direction and turn around to flow proximally alongthe non-helical return portion of the infusant path 514 a and throughthe gap 522 to exit the pump via the proximal cavity outlet 508.Although shown as a single distal-to-proximal line, in some embodiments,exit flow can be induced along and generally following the shape of theinner surface 512 to the proximal cavity outlet 508. In use, as theinfusant passes through the gap 522, the infusant can act as ahydrodynamic bearing (e.g., in addition to the hydrodynamic bearing thatmay be present between the impeller shaft and the bearing housing asdescribed herein). This hydrodynamic bearing can generally be in theshape of a cylinder that extends axially, as defined by the gap 522.Advantageously, this hydrodynamic bearing can reduce friction betweenthe diffuser 502 a and the bearing housing 228.

As illustrated in FIG. 13B, the infusant path 514 b can extend from theproximal end 504 b to the distal end 505 b. As illustrated in FIG. 13B,the infusant path 514 b is helical (e.g., can encircle the impellershaft 204 one or more times along the axial length of the path). In use,as shown in FIG. 13B, generally all of the infusant flows proximally todistally within a distal portion of the bearing assembly 220 and exitsthe bearing assembly at the cavity 520 to enter the chamber 506. Invarious embodiments, a portion of the infusant flows proximally within aproximal portion of the bearing assembly 220 through a space between thedrive shaft 148 and the catheter body 120. This return flow is discussedabove, e.g., in connection with arrow 304 in FIG. 8. At least a portionof the infusant then follows the infusant path 514 b to travel helicallyaround the impeller shaft 204 in the distal direction and out throughthe distal cavity outlet 510. As illustrated in FIG. 13B, the distalcavity outlet 510 defines a gap between the distal end 505 b of diffuser502 b and the proximal end of impeller hub 208. In use, as the infusantpasses through the distal cavity outlet 510, the infusant can act as ahydrodynamic bearing. This hydrodynamic bearing can generally be in theshape of a cylinder having a length extending axially along the lengthof the gap and a radius corresponding to the cross sectional radius ofthe gap. Advantageously, this layer of infusant between the diffuser andthe impeller hub can reduce friction between the diffuser 502 b and theimpeller hub 208 when the pump is in operation.

As described herein, the diffuser 502 a, 502 b can be expandable. Insome embodiments, one or more forces exerted by the infusant can be usedto expand the diffuser 502 a, 502 b. The flow rate of the infusant canbe sufficient to establish an area of positive pressure within thediffuser 502 a, 502 b, thereby allowing at least a portion of theinfusant to exit adjacent to a distal end of the device. In someembodiments, the static pressure of the infusant entering the chamber506 can cause the diffuser 502 a, 502 b to expand. In any of theseembodiments, an inflated diffuser 502 a, 502 b can be deflated byinterrupting and/or discontinuing the flow of infusant into the diffuser502 a, 502 b and by allowing the infusant to exit the diffuser via theproximal outlet 508 or the distal outlet 510. In some embodiments, thewall is elastic but the pliability is relatively low such that uponremoval of the infusant flow a transition from expanded to low profileis rapid. The diffuser 502 a, 502 b self-collapses displacing theinfusant out of the chamber 506 through one or more small apertures. Inaddition to promoting quick deflation, the relatively low pliabilitywill provide a uniform diffuser profile, e.g., will not be deformed ordeflected by any varying pressure or flow rate of the blood from theimpeller 200. A lower infusant pressure configuration can also beprovided by increasing the pliability of the structure forming thediffuser 502 a, 502 b. The structure can be of enhanced pliability bymaterial selection or constructions (e.g., by being thinner or adoptingother balloon-like features).

In other embodiments, the centrifugal force exerted by the infusant asit travels along the helical path 514 a, 514 b can be used to expand thediffuser 502 a, 502 b. As illustrated in FIG. 13A, the diffuser 502 acan be connected to the impeller assembly 116. In these embodiments, thediffuser 502 a and the impeller assembly 116 can be rotated. In use,when the impeller assembly 116 and the diffuser 502 a are rotated, theinfusant can also rotate due to, e.g., shear forces generated from thefluid contact with the rotating diffuser 502 a and/or the rotatingimpeller shaft 204. The rotating infusant can exert a pressure on theinner surface 512 to thereby expand the diffuser 502 a from thecollapsed configuration to the expanded configuration. Thus, in someembodiments, the diffuser 502 a can be centrifugally expanded. In yetother embodiments, the diffuser 502 a can be expanded using acombination of static and centrifugal forces.

As illustrated in FIG. 13B, the diffuser 502 b may not be rotatable. Inthese embodiments, when the impeller shaft 204 is rotated, the infusantcan also rotate due to, e.g., shear forces generated from the fluidcontact with the rotating impeller shaft 204. As described herein, therotating infusant can exert a pressure on the inner surface 512 tothereby expand the diffuser 502 b from the collapsed configuration tothe expanded configuration. Thus, in some embodiments, the diffuser 502b can be centrifugally expanded. In yet other embodiments, the diffuser502 b can be expanded using a combination of static and centrifugalforces.

Infusant exiting the diffuser 502 a, 502 b can be continuouslyreplenished with additional infusant via the flow path 514. If theimpeller shaft 204 stops rotating, the pressure generated from rotationcan decrease to match the pressure acting on the outside of the diffuser502 a, 502 b, thereby allowing the diffuser 502 a, 502 b to collapse.

In yet other embodiments, the diffuser 502 a, 502 b can be expandedand/or inflated by a combination of static and centrifugal forces. Forexample, the diffuser 502 a, 502 b can be expanded and/or inflated by acombination of the static force of the infusant as it enters the chamber506 and the centrifugal force of the infusant as it travels along thehelical path 514.

B. Relatively Axially-Moveable Impeller Housing

As illustrated in FIG. 14B, when the impeller and the diffuser 502 arein the proximal position, at least a portion of the impeller (e.g., theblades 212 and/or the hub) and/or the diffuser 502 may be relativelypositioned in a portion of the housing 202 having minimal or no coating,such as an outlet 802 of the housing 202 (e.g., the outlet through whichblood is pumped). In some embodiments, the housing 202 can be movedaxially relative to the impeller and/or the diffuser 502. In someembodiments, the housing 202 is moved axially over the impeller and theimpeller is stationary. Those skilled in the art may appreciate that insome embodiments, the housing 202 may not be configured to move axiallyrelative to the impeller and/or the diffuser 502 (e.g., housing 202 isfixed or stationary relative to impeller and/or the diffuser 502). Forexample, the housing 202 and the diffuser 502 can be spaced apart by arelatively constant axial distance in all operational states, or atleast in a collapsed and an expanded state.

As illustrated in FIGS. 14A and 14B and as described herein, the rod 332provided between the catheter body 120 and the bearing housing 228enables a slideable engagement between the catheter body 120 and thebearing housing 228. The distal end of the catheter body 120 can beconnected to the proximal portion 268 of the impeller housing 202. Thecatheter body 120 can translate distally from a proximal position to adistal position, and vice versa, by the application of an axial forcedescribed further herein. As described herein, for example with respectto FIGS. 4A-4B, the catheter body 120 can be coupled to the proximalportion 268 of the impeller housing 202. For example, the proximalportion 268 of the impeller housing 202 can be fitted over the distalend of the catheter body 120.

In the proximal position, illustrated in FIG. 14A, the axial position ofthe outlet 802 can be proximal of the axial position of theproximal-most blade 212. In the distal position, illustrated in FIG.14B, the axial position of the outlet 802 can generally correspond tothe axial position of the proximal-most blade 212. Advantageously, therod 332 and the enlarged depression 344 can control the axial distanceover which the impeller housing 202 is capable of sliding. The rod 332can also advantageously prevent the bearing housing 228 from rotatingwith the impeller shaft 204.

Those skilled in the art may appreciate that the axial movement of thecatheter body 120 and the impeller housing 202 relative to the impellerand/or the diffuser 502 can have the same relative effect as axiallymoving the impeller and/or the diffuser 502 relative to the catheterbody 120 or the impeller housing 202, even if the impeller and/or thediffuser are not actually moved axially. Accordingly, in someembodiments the catheter body 120 in the proximal position can bereferred to as the deployed position of the impeller and/or the diffuser502. The catheter body 120 in the distal position can be referred to asthe retracted position of the impeller and/or the diffuser 502.

The ability of the impeller and/or the diffuser 502 to be retracted anddeployed relative to the impeller housing can have many advantages. Forexample, axial movement of the impeller housing relative to the impellerand/or the diffuser can reduce the profile of the pump to ease insertionand retrieval. In some embodiments, in the retracted position, theimpeller hub 208, blades 212, and/or diffuser 502 can be positioned atthe same axial location as a portion of the housing 202 that does nothave a covering (e.g., the outlet 802). Accordingly, the cross-sectionalarea of the catheter assembly 100 measured at the axial position of thediffuser 502 in the retracted position, for example, is comparativelysmaller than when it is in the deployed position. The smaller crosssectional area can be advantageous for minimizing trauma to a userduring insertion into and/or retrieval from the body.

In other embodiments, the retracted position of the impeller and/or thediffuser can be distal of the deployed position of the impeller and/orthe diffuser. In some embodiments, the impeller housing can have arigidity that varies axially. For example, the impeller housing can havea proximal portion that is more rigid (e.g., less flexible) than adistal portion. In these embodiments, the impeller and/or the diffusercan reside in the proximal, rigid portion while in the deployedposition. The impeller and/or the diffuser can reside in the distal,flexible portion while in the retracted position. Advantageously, whenthe impeller and/or the diffuser reside in the flexible portion of theimpeller housing, this portion of the pump may be collapsed to a lowerprofile than would otherwise be achievable if the impeller and/or thediffuser remained in the rigid portion of the impeller housing.

As described herein, the catheter body can be coupled to the impellerhousing. The retraction and deployment (e.g., movement between proximaland distal positions) of the impeller housing can be controlled bymanipulation of a proximal end of the catheter assembly that results inan application of axial force to the catheter body. For example, theimpeller housing can be moved axially by the rotational force applied bya nut disposed at the proximal end of the catheter assembly. A sectionof the proximal end of the catheter assembly is illustrated in FIGS. 15Aand 15B.

In some embodiments, axial force is applied to the catheter body via animpeller deployment assembly 800. The impeller deployment assemblyincludes a nut 804 that is engaged with a portion of the catheterassembly, such as a flow diverter 806. As described herein, the flowdiverter 806 can be a part of the infusion inflow assembly 150,illustrated in FIG. 1. The distal end of the flow diverter 806 can beconnected to a proximal portion of the catheter body. In someembodiments, the nut 804 can be engaged with a pin 808. The pin 808 canpenetrate through the wall of the drive housing 450 and can be coupledwith or fixedly attached to the flow diverter 806. The nut 804 can bedisposed over at least a portion of the drive housing 450 and/or theflow diverter 806. The nut 804 can include an internal engagementstructure that is configured to engage the flow diverter 806 (e.g., viathe pin 808). In some embodiments, the internal engagement structure caninclude internal threading. In other embodiments, the internalengagement structure can include a cam track 812 having first and secondends (e.g., a proximal end and a distal end), as illustrated in FIG.15C. In these embodiments, the pin 808 can be configured to travel alongthe cam track 812. The internal engagement structure can be generallyhelical. The drive housing 450 can also include a longitudinal channel810 along which the pin 808 can travel.

As illustrated in FIGS. 15A and 15B, the drive housing 450 can containthe support shaft 458 and the drive shaft 148. The drive housing 450 canalso capture the nut 804. For example, a retention structure can beformed in the outside surface of the housing 450 to prevent the nut 804from slipping proximally or distally relative to the housing 450. Oneembodiment of a retention structure is illustrated below in connectionwith the deployment device of FIGS. 15D-F but can be included with thedeployment device 800 as well. The pin 808 can penetrate the wall of thedrive housing 450 and permit axial translation of the flow diverter 806by acting as a cam. In some embodiments, the support shaft 458 and thethread advance nut 804 may be rotatable but not translatable relative tothe drive housing 450.

In use, a rotational force can be applied to the nut 804. Thisapplication of rotational force can be converted into an axial forcethat is applied to the flow diverter 806 and the catheter body. Asdescribed herein, the pin 808 can be fixedly attached to the flowdiverter 806 at one end and have a second end disposed within the innersurface of the nut 804 along the cam track thereof. The rotation of thenut 804 in a first direction (e.g., clockwise or counter-clockwise) cancause the pin 808 to translate from a proximal position (e.g., proximalend) to a distal position (e.g., distal end) in the longitudinal channel810. Accordingly, the flow diverter 806, the catheter body, and theimpeller housing can also translate from a proximal position to a distalposition. As described herein, the distal translation of the catheterbody and the impeller housing can improve the ease of the retraction ofthe impeller hub and the blades into the impeller housing. Inembodiments where the outlet 802 is generally free of a polymericcoating, relative movement of at least a portion of the impeller and/orthe diffuser proximally into the outlet 802 or distally into a moreflexible region of the impeller housing (i.e., mid section of thehousing where there is less strut material) can advantageously reducethe profile of the pump upon collapsing into the sheath. In addition,axial adjustment of the impeller housing relative to the impeller canadvantageously promote more efficient flow dynamics. In someembodiments, the impeller is positioned closer to the outlet 802 thanthe middle portion of the housing in order to improve flow dynamics.

A rotational force applied to the nut 804 in a second direction (e.g.,counter-clockwise or clockwise) can cause the pin 808 to translate fromthe distal position to the proximal position. Accordingly, the flowdiverter 806, the catheter body 120, and the impeller housing 202 canalso translate from a distal position to a proximal position. Asdescribed herein, the proximal translation of the catheter body 120 andthe impeller housing 202 can effectively result in the deployment of theimpeller hub 208 and the blades 212.

FIGS. 15D-F illustrate another embodiment of a deployment device 850that can be used to manipulate or deploy a distal structure of thecatheter assembly and/or the impeller housing. As with the deploymentdevice 800, the deployment device 850 can be used to actuate theimpeller 200 between retracted and deployed configurations.

As discussed above, the catheter assembly can include a flow diverter852 that is part of the infusion system. The flow diverter 852 may becoupled with a proximal portion 122 of the catheter body 120. In oneembodiment, the proximal end of the proximal portion 122 is insertedinto a recess 854 formed at a distal 852 a end of the flow diverter 852.The connection between the proximal portion 122 of the catheter body 120the flow diverter 852 can be further made secure by a strain relief 856disposed at the junction and extending distally thereof. The strainrelief 856 overlaps a proximal length of the proximal portion 122 andabsorbs movements of the portions of the catheter assembly to isolatethe connection between the flow diverter 852 and the catheter body. Acap 860 can be used to securely couple strain relief 856 to the flowdiverter 852. A proximal portion 862 of the flow diverter 852 isreceived within a recess 864 of the housing 450. A seal device 866, suchas an O-ring, may be provided between the proximal portion 862 of theflow diverter 852 and inside surface of the recess 864 to preventinfusion from exiting the housing 450 in an undesirable manner.

The flow diverter 852 also includes a lumen 868 that extends from aproximal end 852 b to the distal end 852 a thereof. The lumen 868 isconfigured to permit a proximal portion of the drive shaft 148 to residetherein. In some embodiments, flow diverter 852 is configured to causesome infusant to flow proximally in the lumen 868 between the driveshaft 148 and the inner surface of the flow diverter 852 that forms thelumen 868 to lubricate and cool the drive shaft. The flow diverter 852can be configured to cause most or substantially all of the infusantentering the diverter through the lumen in the catheter body 154 to flowdistally between the catheter body 120 and the drive shaft 148. In onearrangement, the lumen 868 is enlarged from a location proximal of wherethe catheter body 154 couples with the flow diverter 852 toward thedistal end 852 a of the flow diverter. This enlargement creates a pathof least resistance toward the distal direction to divert the flowdistally. In one embodiment, the lumen 868 is further enlarged at alocation between where the catheter body 154 couples with the flowdiverter 852 and the recess 854 such that a substantially continuouslumen can be formed to keep flow resistance at the junction between theflow diverter 852 and the proximal portion 122 of the catheter body 120to a minimum.

The deployment device 850 includes a guide track 872 on a proximalportion 862 of the flow diverter 852, a guide member 874, and anactuator 876. The guide track 872 can comprise an axially oriented slotor recess formed in the outside surface of the proximal portion 862. Theguide track 872 may be configured to slidably receive a guide member 874such that relative movement can be provided between the guide track 872and a guide member 874. A portion of the guide member 874 may extendthrough sidewall of the drive housing 450 such that the axial positionof the guide member 874 can be fixed and relative movement is providedby movement of the flow diverter 852 relative to the guide member. Inone embodiment the guide member 874 is a pin that has one end receivedin a small hole in the drive housing 450 and the other end disposed inthe guide track 872.

The actuator 876 is configured to translate rotational motion thereofinto axial motion of the flow diverter 852. For example, the actuator876 can comprise a nut that includes internal threads that are engagedwith external threads on the outside surface of the flow diverter 852.In various embodiments, a proximal portion of the actuator 876 isanchored to the drive housing 450 to prevent the actuator 876 frommoving axially along the drive housing. In one embodiment a retentionstructure 882 is provided between the actuator 876 and the drive housing450. One embodiment of the retention structure 882 is illustrated indetail B of FIG. 15D. In particular, the retention structure 882includes an inwardly protruding member 884 that is received in anannular recess formed in the outside surface of the drive housing 450.The protruding member 890 can include an inwardly protruding ring havingn diameter that is less than the diameter of the actuator 876 distallyand proximally of the protruding member 884.

FIGS. 15E-F illustrate operation of the deployment device. FIG. 15Ecorresponds to an expanded configuration of the catheter assembly 100.In this position, the pin 874 is positioned at the distal end of theguide track 872 and the flow diverter 852 is in a proximal position.Because the flow diverter 852, the catheter body 120, and the impellerhousing are coupled together so that they move in unison, the catheterbody 120 and the impeller housing are also positioned in a relativelyproximal position. Relative axial movement is permitted between theimpeller and the catheter body, as well as between the diffuser and thecatheter body. Also, because the catheter body 120, the flow diverter852, and the impeller housing move in unison, relative axial movement ispermitted between the impeller (and/or diffuser) and the impellerhousing. As a result, the impeller will be in a more distal positionrelative to the impeller housing when the catheter assembly 100 is inthe configuration of FIG. 15E. The more distal position moves theimpeller into the largest volume portion of the impeller housingenabling the impeller to expand.

FIG. 15F corresponds to a collapsed configuration of the catheterassembly 100. In this position, the pin 874 is positioned at theproximal end of the guide track 872 and the flow diverter 852 is in adistal position. This causes the impeller to be in a more proximalposition relative to the housing when the catheter assembly is in theconfiguration of FIG. 15F. This more proximal position moves theimpeller into engagement with the inside surface of the housing tendingto collapse the impeller.

To move from the expanded configuration of FIG. 15E to the collapsedconfiguration of FIG. 15F, the actuator 876 is rotated in a manner thatcauses the threads to act upon each other which creates axial movementof the catheter body 120 and the impeller housing 202.

C. Impellers Having Self-Sealing Impeller Tips and Lumens with Valves

In some embodiments, the tip 602 of impeller hub 208 can beself-sealable or resealable (e.g., configured to automaticallyeffectively form a seal to substantially stop the flow of a fluid in theabsence of direct action by a user or operator to form the seal), asillustrated in FIGS. 16A-C. As illustrated in FIGS. 16B-C, the tip 602of impeller hub 208 can include a resealable member having a resealablepath therethrough.

As shown in FIG. 16A, the impeller tip 602 can be made of an elastomericmaterial (e.g., a silicone or polyisoprene polymer). As shown in FIG.16A, the tip 602 can include a resealable path 604 that extends alongthe length of the tip. The resealable path 604 can extend from the outersurface at the distal end of tip 602 to the impeller shaft, which can behollow. The hollow shaft extension 606 is shown in FIGS. 16A and 16Bconnected by the resealable path 604 to the tip 602 and is connected atits proximal end to the impeller shaft 204. Thus, the resealable path604 can extend from the impeller shaft 204 to the outer surface of thetip 602. The resealable path 604 can be configured for guidewirepassage. The resealable path 604 can generally pass through the centerof rotation of the impeller tip 602.

The resealable path 604 can be created using a very small diameter,e.g., a 32 gauge (0.00925 inch or 0.235 mm) wire or pin. In someembodiments, the resealable path 604 can be created without coring theimpeller tip 602 (e.g., without punching out or otherwise removing acylinder of material). The resealable path 604 can be self-sealable. Forexample, the resealable path 604 can close or seal automatically,without the use of additional tools or implements. The resealable path604 can be self-sealable due to the elastomeric properties of thematerial used for impeller tip 602 (e.g., a silicone or polyisoprenepolymer) and/or the diameter of the resealable path 604. In someembodiments, circumferential and radial forces of the tip materialand/or external pressure forces (illustrated with arrows at 612) exertedwhile the catheter assembly 100 is implanted can also contribute tosealing the resealable path 604.

In some embodiments, the tip 602 or resealable member 622, 624 can bemade of the same material as the rest of the impeller system (e.g., hub,blades, shaft, and/or shaft extension). In other embodiments, the tip602 or resealable member 622, 624 can be made from a different materialthan the rest of the impeller system (e.g., hub, blades, shaft, and/orshaft extension). For example, the tip 602 or resealable member 622, 624can be made of a material that is more elastomeric (e.g., has greaterelasticity) than the material from which the impeller shaft 204 and/orshaft extension 606 are formed. In another example, the tip 602 orresealable member 622, 624 can be made from a polyisoprene polymer andat least a portion of the impeller shaft 204 (e.g., the distal end)and/or shaft extension 606 are formed from an acrylonitrile butadienestyrene (ABS) polymer or a polycarbonate polymer.

In some embodiments where the impeller tip 602 comprises a resealablemember 622 that is made separately from the rest of the impeller system,the resealable member 622 can include one or more proximally-extendingtabs 616. The one or more tabs 616 can be disposed about the proximalend of resealable member 622. In some embodiments, the resealable member622 can include one generally cylindrical tab 616 that is disposed aboutthe proximal end of the resealable member 622. The one or more tabs 616can be configured to mate with (e.g., can engage and/or be disposedwithin) one or more of the corresponding recesses 618 disposed on thedistal end of a portion of the impeller assembly 116 (e.g., the hub 208,shaft 204, and/or shaft extension 606). As illustrated in FIG. 16B, therecess 618 can be bounded by the surfaces of the hub 208 and the shaftextension 606. The one or more recesses 618 can be disposed about thedistal end of impeller assembly 116. In some embodiments, the distal endof the impeller assembly 116 can include one recess 618. For example,the recess 618 can be a generally cylindrical channel surrounding atleast a portion of the shaft extension 606.

Engagement of the resealable member 622 with the distal end of theimpeller assembly 116 as illustrated in FIG. 16B can have manyadvantages. For example, an interface 620 between the resealable member622 and the distal end of the impeller assembly 116 can be non-planar.Accordingly, a non-planar interface 620 can have a greater surface areathan an otherwise similar interface that is planar. The increasedsurface area can advantageously increase the connection strength betweenthe resealable member 622 and the distal end of the impeller assembly116. In one embodiment, the interface 620 can be much longer than theradial distance from the lumen 610 to the outer surface of the hub 208.For example, the interface 620 can be at least about twice as long asthis radial distance.

As illustrated in FIG. 16B, resealable member 622 can include a valve608 that extends proximally into an axial lumen 610. One valve structurethat can be used is a duck bill valve. The lumen 610 can pass throughone or more components of the distal end of the impeller assembly 116,such as the impeller shaft 204, the impeller shaft extension 606, and/orthe hub 208. The lumen 610 can have a diameter that is greater than thediameter of the resealable path 604. The lumen 610 may also not beself-sealing. The valve 608 can be tapered or otherwise have a reducedcross section compared to the lumen 610. As a result, the impeller tipcan also include one or more corners 614 where the lumen 610 extendsdistally to overlap with the valve 608. The outer surface of valve 608can be separated by a distance from the inner surface of the resealablemember 622. Advantageously, where the pressure within the lumen 610 isgreater than the pressure outside the catheter assembly 100, theinternal pressure can be exerted on valve 608 to close resealable path604. The proximal extension of the valve 608 into the lumen 610 can alsopromote easier entry of a guidewire into the lumen 610 when theguidewire is introduced from the distal end of the pump. Other valvesstructures that may be used in place of the valve 608 are discussed inU.S. application Ser. No. 12/829,359 and in U.S. Pat. No. 7,022,100,which are incorporated by reference herein for all purposes and in itsentirety.

Another embodiment of an impeller tip 602 that includes a resealablemember 624 is illustrated in FIG. 16C. The resealable member 624 canhave a resealable path 630 therethrough. The resealable member 624 canoptionally include a distal tapered portion. As described herein, theimpeller can be coupled with the catheter body through a drive shaft148, which can be disposed or received within the axial lumen of theimpeller or within the impeller shaft 204. As illustrated in FIG. 16C, adistal portion of a shaft, e.g., the drive shaft 148 or the impellershaft 204, can be disposed or received within the resealable member 624.The impeller tip 602 can further include a non-resealable portion 626having a non-resealable path 628 extending therethrough (e.g., a paththat generally does not seal or close once it has been opened orcreated, and/or remains permanently open allowing fluid to passtherethrough). The resealable path 630 and the non-resealable path 628can be co-linear (e.g., coaxial). As illustrated in FIG. 16C, thenon-resealable portion 626 can extend distally of the resealable member624. In some embodiments, the non-resealable portion 626 can partiallyor fully surround an outer surface of the resealable member 624. Forexample, the resealable member 624 can be partially or entirelycontained within the non-resealable portion 626. As illustrated in FIG.16C, the non-resealable portion 626 can include the distal-most portionof the impeller tip 602. In some embodiments, the non-resealable portion626 can be a unitary structure that includes the hub and one or moreblades of the impeller. In one embodiment, the non-resealable portion626 can include the entire impeller body except for the resealablemember 624. For example, as discussed above, the impeller can include ahub disposed between the impeller blades and the impeller shaft 204. Theimpeller hub can surround the resealable member 624.

Advantageously, the impeller tip 602 can be configured to receive aguidewire through both the resealable path and the non-resealable path628. In some embodiments, the resealable path (when open) and/or thenon-resealable path can have a diameter that is no more than one-halfthe diameter of the guidewire. Where the impeller tip 602 includes aresealable member 624 disposed therein, the resealable member can beadvantageously protected from the trauma to which the outer surface ofthe impeller tip 602 may be exposed. In addition, the distally-extendingnon-resealable path can act as a guide or channel that directs theguidewire through the impeller. Furthermore, as discussed herein, thetapered shape of the distal portion of the resealable member 624 canhelp to reseal the resealable member 624, as radial forces extendinginwards can surround the tapered portion and help to close theresealable path. Note in this case that the non-resealable member, alsomade of an elastomeric material (but different actual material), retainsa level of elasticity that can stretch to a lesser degree than theresealable material to accommodate passage of the guidewire.

The impeller tip 602 illustrated in FIG. 16C can be manufactured byfirst molding a soft and/or elastomeric material over at least a portionof the drive shaft 148 of the impeller shaft 204 to form the resealablemember 624. Some suitable materials for forming the member 624 includepolyurethane and silicone. Some materials having low durometer, e.g.,below 60A, can be used for the resealable member 624. In someembodiments, the material can have a durometer in the range of fromabout 25A to about 55A. For example, the material can be a polyurethaneor a silicone polymer having a durometer below 60A (e.g., in the rangeof from about 25A to about 55A). In some embodiments with a polyurethanematerial, the hardness can be for example, about 25A, about 35A, about45A, or about 55A. In other embodiments, a silicone material can be usedfor the tip 602 and/or the resealable member 622, 624. The siliconematerial can have a hardness ranging from about 20A to about 60A. Insome embodiments, the hardness can be about 38A. As described above, theresealable member 624 can optionally be formed to include a distaltapered portion. The rest of the impeller, or a portion thereof, canthen be molded over the resealable member 624 and the drive shaft 148.The remainder of the impeller tip 602 can be formed from a secondmaterial (e.g., a second polymer) that is different from the materialused to form the resealable member 624. The non-resealable path 628 andthe resealable path 630 can be created after the impeller is molded overthe drive shaft 148 or the impeller shaft 204. A variety of methodsand/or tools can be used to create these paths, including but notlimited to a drill, a needle, or a small gauge screw. In someembodiments, the paths 628, 630 can be formed from a proximal end to adistal end of a wall of the impeller hub, e.g., distal of the distalmost blade. In other embodiments, the paths 628 can be formed from adistal end of the impeller toward a proximal end of the impeller.

In use, those skilled in the art may appreciate that non-sealable (e.g.,non-resealable or non-self-sealing) devices may require a constant flowof infusant in the distal direction to prevent the proximal flow offluid or blood into the device. Advantageously, a resealable tip canallow for guidewire passage through the center of the catheter assembly100 to ease insertion without requiring a constant flush of infusant.The tip in various embodiments the resealable tip self-seals when theguidewire is removed. Valves discussed herein provide the advantage ofpreventing blood from entering other portions of the catheter assembly100, such as the impeller shaft 204 or the lumen 234 or the bearinghousing 228. In various embodiments, valves are configured to beactuated from an at least partially open configuration to a closedconfiguration, such as by application of a force or pressure on one sidethereof.

D. Sheath Having Expandable Distal End

As described herein, the pump can include a sheath assembly. The sheathassembly can control the collapse and expansion of the impeller and/orthe impeller housing. In some embodiments, the distal end of the sheathassembly can optionally include one or more structures that aid in thedeployment and/or retrieval of the impeller assembly.

In some embodiments, as shown in FIGS. 17A to 17D, the sheath assemblycan include an expandable distal end 170 a, 170 b, 170 c. For example,the distal end can expand when a radial force is applied, and cancontract when the radial force is removed. The distal end may also beable to expand and/or contract repeatedly. When expanded, the distal end170 a, 170 b, 170 c can have a conical and/or funnel-like configuration.When not expanded, the distal end 170 a, 170 b, 170 c can have agenerally cylindrical (e.g., generally constant diameter) configuration,for example as illustrated in FIG. 17A. To assist with expansion and/orcontraction, the distal end 170 a, 170 b, 170 c or portions thereof maybe made from materials having a different flexibility and/or elasticity(e.g., more or less flexible and/or elastic) than the material(s) usedfor all or a portion of the remainder of the sheath assembly. In someembodiments, the sheath assembly 162 can have at least one configurationwhere it is at least partially disposed over the impeller housing,catheter assembly, and/or impeller assembly. Advantageously, the conicaland/or funnel-like configuration can aid the deployment and/orretraction of the impeller assembly and/or impeller housing as describedherein.

As illustrated in FIG. 17A, the distal end 170 a can include one or moreaxial slits 702 (e.g., 2, 3, or 4 slits). Slit 702 can extend proximallyfrom the distal end 170 a at least partially along the length of theelongate body 174. The distal end 170 a can also include a plurality ofelongate members 704 (e.g., 2, 3, or 4 elongate members). Each elongatemember 704 can be joined at one end (e.g., proximal end) to the sheathassembly. Each elongate member 704 can also have a distal end 705 thatis outwardly deflectable away from axis 708. The elongate members 704can be separated from each other by the slits 702. Each elongate member704 can have a width that is defined by the distance between slits 702and a length defined by the length of each adjacent slit 702. In someembodiments, the elongate members 704 and slits 702 can be generallyequally spaced circumferentially about the elongate body 174. In someembodiments, the elongate members 704 can each have a length that isgenerally equal to or greater than the axial length of the outletportion of the impeller housing. For example, in some embodiments, theelongate members 704 can each have a length in the range of from about0.25 in. up to about 2.0 in. In other embodiments, the elongate members704 can each have a length in the range of from about 0.5 in to about0.75 in. The elongate members 704 and/or at least a portion of thesheath assembly 162 (e.g., the portion of the sheath assembly 162 thatconnects to elongate members 704) can be made from a relatively elasticmaterial (e.g., any of the elastomeric polymers described herein).

In use, an outwardly-acting radial force resulting from the radialstiffness of the impeller housing can be applied to the elongate members704 which causes the elongate members 704 to deflect outwards, asillustrated in FIG. 17B. For example, the axial movement of the impellerhousing in the proximal direction into the sheath assembly (or distalmovement of the sheath over the expanded impeller housing) can cause theelongate members 704 to deflect outwards. The outward deflection of theelongate members 704 can result in the conical or funnel-likeconfiguration of the distal end 170 a when sheathed over an expandedsection of the impeller housing. When the elongate members 704 aredeflected outwards, the width of each slit 702 can increase at thedistal end to define a gap 709. In some embodiments, the elongatemembers 704 can be self-collapsing. For example, the elongate members704 can be configured to return to their original configuration when theinternal outward-acting radial forces are released (e.g., where theelongate members 704 are made of a relatively elastic material).

As illustrated in FIG. 17C, the distal end 170 b of the sheath assemblycan include an deformable structure 706 (e.g., a webbing) that at leastpartially covers one or more slits 702. In some embodiments, thedeformable (e.g., stretchable, expandable, flexible, and/or elastic)structure 706 can surround, coat, and/or cover at least a portion of thedistal end 170 b (e.g., the elongate members 704). As illustrated inFIG. 17C, the deformable structure 706 can be an elastomeric coating(e.g., incorporating those elastomeric materials described herein). Inother embodiments, the deformable structure 706 can include a spring,such as a semi-circular spring member having a straight or oscillatorypattern. In use, the deformable structure 706 can be configured toreturn the elongate members 704 to their original, non-conicalconfiguration and/or prevent over-deflection of the elongate members 704beyond their elastic limit.

In some embodiments, the elongate members 704 can be stiffer (in thecircumferential and/or axial direction(s)) than the proximally-adjacentportion of the sheath assembly. Advantageously, the stiffer material canprevent or inhibit the distal-most end of the sheath assembly fromfolding over itself when it encounters resistance (e.g., advancing thesheath over an expanded cannula housing). In one embodiment, one or moreelongate members 704 can be reinforced with a plurality of wires thatextend to the distal-most tip of the elongate member 704. In anotherembodiment, one or more elongate members 704 can be made from a polymerthat is stiffer than the material (e.g., a second polymer) of theproximally-adjacent portion of the sheath assembly.

As illustrated in FIG. 17D, in some embodiments the distal end 170 c ofsheath assembly 162 can include an integral funnel 710 having a distal,conically-shaped portion 711. As described further herein, the integralfunnel 710 can be expandable and/or collapsible. Advantageously, theintegral funnel 710 can assist in deployment and retraction of thehousing while minimally increasing the profile of the pump. The integralfunnel 710 can be connected to a non-expandable portion 712 of thesheath, for example, at a distal-most tip 714. The integral funnel 710can include an outer layer 713 and an inner layer 715 that converge atan interface 717. The integral funnel 710 can be layered over an outersurface 716 and over an inner surface 718 of the non-expandable portion712. Accordingly, as illustrated in FIG. 17D, at least a portion of theinner layer 715 can reside, at least temporarily, within the lumen ofthe sheath assembly 162. The integral funnel 708 can be connected toeither the outer surface 716 or the inner surface 718 of the sheath. Insome embodiments, the funnel 710 can be a distal extension of distal end170 that is folded over the non-expandable portion 712.

The integral funnel 710 can be slideable over the outer surface 716and/or the inner surface 718 of the non-expandable portion 712. Thecontact surfaces between the non-expandable portion 712 and the integralfunnel 710 and/or between the outer layer 713 and the inner layer 715can be lubricated, e.g., using a silicone lubricant, to establish and/ormaintain slideability and/or low friction. The integral funnel 710 canbe made from a thin, flexible material, such as a polyurethane polymer.In some embodiments, the integral funnel 710 can be made from a materialthat is more flexible and/or elastic than the material that is used forall or a portion of the remainder of the sheath assembly. In someembodiments, the material used for the integral funnel 710 can have oneor more membrane-like qualities. In use, the axial movement of thehousing 202 (not shown) can frictionally engage the integral funnel 710,causing the integral funnel 710 to deploy or retract. For example, inembodiments where the outer layer 713 is affixed to the non-expandableportion 712 of the sheath, axial movement of the housing 202 in a distaldirection can cause the inner layer 715 to translate distally (e.g.,slide distally along the inner surface 718 of the sheath), thusdeploying the conical portion 711 (e.g., pulling the conical portion 711out of the sheath). Axial movement of the housing in a proximaldirection can cause the inner layer 715 to translate proximally (e.g.,slide proximally along the inner surface 718 of the sheath), thusretracting the conical portion 711 into the sheath (e.g., pulling theconical portion 711 into the sheath). The thin, flexible material of theconical portion 711 can advantageously allow the conical portion 711 todeform upon retraction into the sheath.

In embodiments where the inner layer 715 is affixed to thenon-expandable portion of the sheath, axial movement of the housing 202can cause the outer layer 713 to translate. For example, distal movementof the housing can cause the outer layer 713 to slide distally along theouter surface 716 of the sheath. Proximal movement of the housing cancause the outer layer 713 to slide proximally along the outer surface716 of the sheath.

In some embodiments where the funnel 710 is a distal extension of thenon-expandable portion 712 that is folded over the non-expandableportion 712, the funnel 710 can slide distally as the non-expandableportion 712 is moved proximally. In use, as the non-expandable portion712 is moved proximally, the funnel 710 can slide distally to unfold andsurround the impeller assembly 116.

IV. Methods

Various methods and techniques are discussed above in connection withspecific structures of heart pumps. The following elaborates on someaspects of these techniques and methods. The following discussion is tobe read in light of and freely combined with the foregoing discussion.

A. Retracting and Deploying the Impeller Housing by Way of the ImpellerDeployment Assembly at the Proximal End of the Catheter Body

As discussed above, in various embodiments the heart pump 10 is insertedin a less invasive manner, e.g., using techniques that can be employedin a catheter lab. Various general techniques pertinent to the heartpump 10 are described in U.S. patent application Ser. No. 12/829,359,filed on Jul. 1, 2010, and entitled Blood Pump With Expandable Cannula,which is incorporated by reference herein in its entirety and for allpurposes.

Because the catheter assembly 100 is to be delivered through a smallaccess site, it can be important to ensure that the impeller housing isreliably deployed and retracted, as described above. A clinician maybegin a heart pumping procedure by introducing the catheter assembly 100into the patient percutaneously, e.g., by urging the catheter assemblythrough the femoral artery and into a heart chamber. Because theimpeller and impeller housing are advanced through a narrow artery insome embodiments, the impeller and impeller housing can initially beinserted into the patient in a retracted, or collapsed (or low profile),state, as described above. Once the distal end of the catheter assembly100 (including the impeller housing) has reached the desired operatinglocation (e.g., a heart chamber), the clinician can deploy the impellerhousing into an advanced or expanded configuration.

One method of deploying the impeller and/or diffuser is by using theimpeller deployment assembly 800, which can be located near the proximalend of the catheter assembly. As shown in FIGS. 15A and 15B, theclinician can rotate the nut 804 (clockwise or counter-clockwisedepending on the threading) such that the nut 804 translates from adistal position to a proximal position. In turn, the flow diverter 806,the catheter body, and the impeller housing can also translate from adistal position to a proximal position and thereby advance the impellerdistally into a wider portion of the impeller housing to allow fordeployment of the impeller hub 208 and blades 212. Thus, in someembodiments, the clinician can deploy the impeller, located at a distalend of the catheter assembly, by rotating a nut disposed near theproximal end of the catheter assembly.

In some embodiments, the impeller 200 and housing 202 can be axiallydisplaced relative to their operational positions during delivery of thedistal end to the heart (e.g., the impeller and housing can be deliveredto the vasculature in an axially separated configuration). As used inthis context, “axially displaced” includes configurations where there isaxial movement of the impeller 200 relative to any portion of thehousing 202 prior to or during the process of delivery. For example,axial displacement includes conditions in which the impeller 200 ismoved from a first position near a proximal end port (outlet for leftside support or inlet for right side support) of the housing 202 to asecond position distal the first position. The second position can beone that is still between the proximal end port and a distal end port(inlet for left side support or outlet for right side support) of thehousing 202. The first position may be the operational position of theimpeller 200 relative to the housing 202. Axial displacement alsoincludes conditions in which the impeller is located proximal of anoperational position, e.g., at a location proximal of a proximal endport of the housing 202, including being disposed within anon-expandable portion of the heart pump. When the clinician deliversthe distal end of the heart pump to the heart chamber, rather thandelivering the distal end with the impeller housing disposed over theimpeller blades, the impeller housing can be in a proximally displacedposition or retracted configuration (or distally displaced position oradvanced configuration in other embodiments) with respect to theimpeller, such that it is axially moved from the operational position,as discussed above.

In some embodiments, the impeller and the housing can be delivered inseries (with the impeller being delivered before the housing, or viceversa). For example, in one embodiment, the impeller housing 202 isfirst advanced into position, e.g., in the heart. The housing 202 maythen be expanded if the housing has expanded and compressedconfigurations. Thereafter the impeller 200 may be positioned, e.g.,advanced through a catheter body similar to the catheter body 120 to bepositioned within the impeller housing 202. Thereafter the impeller 200can be rotated by a source of rotational energy. In various embodiments,the source of rotational energy can comprise a motor positioned outsideof the patient to drive a shaft similar to the shaft 148. In otherembodiment, the source of rotational energy can comprise a motor that isminiaturized to be positionable within the patient, as discussed in U.S.Pat. No. 7,070,555, which is incorporated by reference herein for allpurposes and in its entirety. In another embodiment, the distal end ofthe impeller 200 can be configured to be advanced into position in thepatient and, at a later stage of a procedure, the impeller housing 202can be positioned thereover. In one technique, the impeller 200 ispositioned in the heart chamber (or wherever the procedure is to occur),the clinician can then advance the impeller housing over the impellerblades and begin operating the heart pump. For removal of the catheterassembly from the patient after the procedure, the clinician can retractor displace the impeller housing proximally to axially displace and/orseparate the impeller from the impeller housing.

The configurations enabling displaced or serial delivery also candecouple the design of the impeller housing 202 from the complexities ofthe design of the impeller 200. For example, the impeller housing 202can have a greater range of expansion from a collapsed state to anexpanded state. If no structures are disposed inside the housing 202 inthe collapsed state, greater compression and a lower crossing profilecan be achieved compared to where the housing 202 must be sized in thecollapsed state to accommodate the impeller 200 in its collapsed state.This provides one or more of the benefits of access through smallervessels, in smaller patients, or a larger expanded size in standardpatients through typical access (e.g., femoral vessel). Similarly,greater compression of the impeller 200 may be possible if the impeller200 is delivered using a dedicated compression sheath or device that isnot required to expand and/or to be present around the impeller duringoperation. As a result, larger blades may be delivered from the samecollapsed profile, providing the advantages of higher flow discussedabove. More details of serial delivery of blood pumps are discussed inU.S. Pat. No. 7,022,100, which is incorporated by reference herein forall purposes and in its entirety.

Once the impeller is deployed, the clinician can conduct the procedure,e.g., by running the heart pump within a heart chamber. Once theprocedure is finished, the clinician can remove the catheter assemblyfrom the patient by retracting the impeller. The clinician can simplyrotate the nut 804 in a direction opposite to that rotated for deployingthe impeller. The nut can then translate from the proximal position tothe distal position, which in turn can cause the flow diverter 806, thecatheter body, and the impeller housing to also translate from theproximal position to the distal position. The impeller can thereby beretracted proximally into an area near the outlet 802 to reduce theprofile of the pump upon collapsing into the sheath. Thus, the cliniciancan both deploy and retract the impeller by rotating a nut located nearthe proximal end of the catheter assembly.

B. Controlling the Collapse and Deployment of the Impeller Housing withthe Sheath Assembly

As mentioned above in Section IV(A), it can be advantageous in certainembodiments to enable a clinician to deploy and retract the impellerassembly prior to and after a heart procedure. One method of collapsingthe impeller housing can be performed by advancing the sheath assembly162 distally over the impeller housing to collapse the impellerassembly, e.g., for removal of the catheter assembly from the patientafter a heart procedure. As mentioned above, elongate body 174 of thecatheter assembly 162 can be slidably disposed over the catheter body120. The clinician can distally advance the elongate body 174 over theimpeller housing, or alternatively proximally retract the catheter body120 such that the impeller housing collapses into the elongate body 174of the sheath assembly 162.

As FIGS. 17A-D illustrate, the sheath assembly can have expandabledistal ends 170 a, 170 b, 170 c, that expand when a radial force isapplied. Thus, when the clinician advances the elongate body 174 of thesheath over the impeller housing, the impeller housing can contact thedistal end 170 and can induce a radial force that causes the distal ends170 a, 170 b, 170 c, to expand in order to aid in retraction of theimpeller assembly. Similarly, when the clinician slides the elongatebody 174 in a proximal direction, the impeller assembly can deploythrough the distal end 170 of the catheter assembly 162, because thedistal ends 170 a, 170 b, 170 c, can contract when a radial force isremoved (or not applied). Thus, the clinician can reliably deploy andretract the impeller assembly by sliding the elongate body 174 of thesheath relative to the catheter body 120. In other embodiments, thesheath assembly need not have expandable distal ends as described above.The clinician can therefore simply deploy the impeller assembly 116 byproviding relative motion between the elongate body 174 of the sheathand the impeller assembly, e.g., by retracting the elongate body 174from the impeller assembly, and can collapse the impeller assembly byproviding relative motion between the elongate body 174 of the sheathand the impeller assembly 116, e.g., by advancing the elongate body overthe impeller assembly. The distal end of the elongate body 174 cantherefore effectuate collapse of the impeller assembly 116 without usingthe expandable distal ends described above. In embodiments where theimpeller assembly is self-expanding, the retraction of the elongate body174 from the impeller assembly 116 or extension of the impeller assembly116 out of the elongate body 174 can release the impeller assembly toself-expand.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present embodimentswithout departing from the scope or spirit of the advantages of thepresent application. Thus, it is intended that the present applicationcover the modifications and variations of these embodiments and theirequivalents.

1-23. (canceled)
 24. A method of pumping blood in a patient, the methodcomprising: inserting an impeller housing and impeller into the patient,the impeller disposed within the impeller housing and having alongitudinal axis; positioning the impeller housing and the impeller ata treatment location in the patient; activating an adjustment device ata proximal end portion of the heart pump outside the patient to providerelative motion between the impeller housing and the impeller along thelongitudinal axis; and pumping blood through the impeller housing alongthe longitudinal axis.
 25. The method of claim 24, further comprisingsliding a sheath proximally relative to the impeller housing to causethe impeller housing to expand to an expanded configuration.
 26. Themethod of claim 25, further comprising sliding the sheath distally overthe impeller housing to cause the impeller housing to collapse to astored configuration.
 27. The method of claim 24, wherein providingrelative motion comprises moving the impeller housing from a firstposition in which an outlet of the impeller housing is disposed proximala blade of the impeller to a second position in which the outlet isdisposed adjacent the blade.
 28. The method of claim 24, whereinactivating the adjustment device comprises rotating a nut.
 29. Themethod of claim 28, wherein rotating a nut comprises rotating a nutmechanically connected to the impeller by way of a pin, and whereinrotation of the nut causes the pin and the impeller to translate alongthe longitudinal axis.
 30. The method of claim 24, wherein activating anadjustment device comprises translating a rod connected to the impellerhousing to cause the impeller housing to translate parallel to thelongitudinal axis.
 31. The method of claim 24, wherein inserting animpeller comprises inserting an impeller having a plurality of blades.32. The method of claim 24, wherein inserting an impeller comprisesinserting an impeller that is expandable.
 33. The method of claim 24,wherein inserting an impeller housing comprises inserting an impellerhousing that is expandable.